Maintained by Sreepriya Prasannan

MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist

Compiled from openFDA 510(k) records · Last verified 26 Sep 2026 · Editorial standards

The FDA decided 684 510(k) clearances in the last 90 days. Across all years, 456 clearances have gone to 132 applicants based in Ireland, mostly in Galway, Crumlin, Limerick. The most recent was Medtronic Ireland's NC Euphora Rapid Exchange Balloon Dilatation Catheter on 14 Aug 2026. A 510(k) clearance means the FDA found a device substantially equivalent to one already legally marketed; it is not a premarket approval (PMA).

Irish MedTech: FDA clearances to Irish-based applicants

456 clearances

Device	Applicant	Class	Specialty	Decision
NC Euphora Rapid Exchange Balloon Dilatation Catheter K261428 · Catheters, Transluminal Coronary Angioplasty, Percutaneous	Medtronic Ireland Galway	Class 2	Cardiovascular	14 Aug 2026 Traditional
Millipede System K262399 · Catheter, Thrombus Retriever	Perfuze, Ltd. Galway	Class 2	Cardiovascular	12 Aug 2026 Special
Transurethral Catheter Safety Valve (TUCSV) (80050) K260919 · Accessories, Catheter, G-U	Class Medical , Ltd. Co Limerick	Class 2	Gastroenterology, Urology	5 Aug 2026 Traditional
Euphora Rapid Exchange (RX) Balloon Dilatation Catheter K261759 · Catheters, Transluminal Coronary Angioplasty, Percutaneous	Medtronic Ireland Galway	Class 2	Cardiovascular	27 Jul 2026 Traditional
EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes K261274 · Bronchoscope Accessory	Cook Ireland, Ltd. Limerick	Class 2	Ear, Nose, Throat	24 Jul 2026 Traditional
VERAFEYE Imaging Catheter (VF-VIC-002) K261849 · Catheter, Ultrasound, Intravascular	Luma Vision Limited Dublin	Class 2	Cardiovascular	24 Jul 2026 Special
Merit MAK Nitinol/Gold-Tungsten Guide Wire K261640 · Wire, Guide, Catheter	Merit Medical Ireland , Ltd. Galway	Class 2	Cardiovascular	13 Jul 2026 Special
Millipede88 Access Catheter K253901 · Catheter, Percutaneous, Neurovasculature	Perfuze, Ltd. Galway	Class 2	Cardiovascular	9 Jul 2026 Traditional
ATTUNE Total Knee System; ATTUNE Cementless Knee System K261458 · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	DePuy Ireland UC Cork	Class 2	Orthopedic	25 Jun 2026 Traditional
VELYS Robotic-Assisted Solution K260480 · Orthopedic Stereotaxic Instrument	Depuy Ireland UC Ringaskiddy, Co. Cork	Class 2	Neurology	25 Jun 2026 Traditional
NEUROMARK System (NMK00301) K261833 · Electrosurgical, Cutting & Coagulation & Accessories	Neurent Medical , Ltd. Galway	Class 2	General, Plastic Surgery	16 Jun 2026 Special
VERAFEYE Imaging and Guidance System (VF-VIS-002) K260885	Luma Vision Limited Dublin	—	Unknown	15 Jun 2026 Traditional
GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) K261369 · Gastrointesinal Lesion Software Detection System	Cosmo Artificial Intelligence - Ai, Ltd. Dublin	Class 2	Gastroenterology, Urology	29 May 2026 Special
InQwire Amplatz Guide Wire K254137 · Wire, Guide, Catheter	Merit Medical Ireland, Ltd. Galway	Class 2	Cardiovascular	22 May 2026 Traditional
Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement K260536 · Prosthesis, Hip, Hemi-, Femoral, Metal	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	15 May 2026 Traditional
Enroute 0.014'' Transcarotid Guidewire K253746 · Wire, Guide, Catheter	Lake Region Medical Galway	Class 2	Cardiovascular	19 Mar 2026 Special
Millipede System K253590 · Catheter, Thrombus Retriever	Perfuze, Ltd. Galway	Class 2	Cardiovascular	16 Mar 2026 Traditional
InVera Infusion Device K250794 · Catheter, Continuous Flush	Invera Medical Galway	Class 2	Cardiovascular	12 Mar 2026 Traditional
INHANCE Reverse Shoulder System K253624 · Shoulder Prosthesis, Reverse Configuration	Depuy Ireland UC Cork	Class 2	Orthopedic	11 Mar 2026 Traditional
VELYS Hip Navigation K253551 · Automated Radiological Image Processing Software	Depuy Ireland UC Ringaskiddy, Co. Cork	Class 2	Radiology	6 Mar 2026 Traditional
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) K260043 · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Smart Reactors Galway	Class 2	Cardiovascular	23 Feb 2026 Traditional
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) K253847 · Wire, Guide, Catheter	Merit Medical Ireland, Ltd. Galway	Class 2	Cardiovascular	31 Jan 2026 Special
InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) K251385 · Wire, Guide, Catheter	Merit Medical Ireland, Ltd. Galway	Class 2	Cardiovascular	21 Jan 2026 Traditional
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter K251970 · Catheters, Transluminal Coronary Angioplasty, Percutaneous	Medtronic, Ireland Galway	Class 2	Cardiovascular	17 Jan 2026 Traditional
Esperance pHLO Aspiration System K251357 · Catheter, Thrombus Retriever	Phenox, Ltd. Galway	Class 2	Cardiovascular	15 Jan 2026 Traditional
Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) K242492 · Assayed Quality Control Material For Clinical Microbiology Assays	Techno-Path Manufacturing , Ltd. Co. Tipperary	Class 2	Microbiology	30 Dec 2025 Traditional
VitaloJAK Clinic (Model 7100) K253293 · Recorder, Magnetic Tape, Medical	Vitalograph , Ltd. Ennis Co. Clare	Class 2	Cardiovascular	3 Dec 2025 Special
ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors K253197 · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	19 Nov 2025 Traditional
Telescope Guide Extension Catheter K252390 · Catheter, Percutaneous	Medtronic, Ireland Galway	Class 2	Cardiovascular	29 Oct 2025 Traditional
Glucose2 K252357 · Hexokinase, Glucose	Abbott Ireland Longford	Class 2	Clinical Chemistry	24 Oct 2025 Traditional
PerQseal Introducers K252309 · Introducer, Catheter	Vivasure Medical Limited Galway	Class 2	Cardiovascular	23 Oct 2025 Traditional
EMBOTRAP III Revascularization Device K251789 · Catheter, Thrombus Retriever	Neuravi Limited Galway	Class 2	Cardiovascular	25 Sep 2025 Special
ProVee Video Processing Unit (PV-003) K251734 · Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Proverum Limited Dublin 1	Class 2	Gastroenterology, Urology	24 Sep 2025 Traditional
Aerogen Pro-X1 Controller System K251615 · Ventilator-Compatible Nebulizer	Aerogen, Ltd. Galway	Class 2	Anesthesiology	2 Sep 2025 Traditional
Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set K252392 · Catheter, Thrombus Retriever	Perfuze, Ltd. Galway	Class 2	Cardiovascular	29 Aug 2025 Special
Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT) K251181 · Wire, Guide, Catheter	Merit Medical Ireland, Ltd. Galway	Class 2	Cardiovascular	29 Aug 2025 Special
NeuroTrac® MyoPlus Pro (MYO120U) K243079 · Stimulator, Electrical, Non-Implantable, For Incontinence	Verity Medical , Ltd. Tagoat	Class 2	Gastroenterology, Urology	26 Jun 2025 Traditional
Liberant Thrombectomy System K250787 · Peripheral Mechanical Thrombectomy With Aspiration	Medtronic, Ireland Galway	Class 2	Cardiovascular	11 Jun 2025 Traditional
NEUROMARK System (NMK00301) K250048 · Electrosurgical, Cutting & Coagulation & Accessories	Neurent Medical , Ltd. Galway	Class 2	General, Plastic Surgery	29 May 2025 Traditional
RECLAIM Monobloc Revision Femoral Stem K251292 · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Depuy Ireland UC Cork	Class 2	Orthopedic	23 May 2025 Special
Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) K250256 · Tube, Tympanostomy	Aventamed Dac Bishopstown	Class 2	Ear, Nose, Throat	28 Apr 2025 Traditional
Préime DermaFacial Collagen+ K243055 · Massager, Vacuum, Radio Frequency Induced Heat	EMA Aesthetics , Ltd. Dublin 2	Class 2	General, Plastic Surgery	15 Apr 2025 Traditional
Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001); Pre-B Seal Lung Biopsy Plug System - 16cm Model (FG0002); Pre-B Seal Lung Biopsy Plug System - 20cm Model (FG0003) K243722 · Absorbable Lung Biopsy Plug	Selio Medical Limited Dublin	Class 2	General, Plastic Surgery	8 Apr 2025 Traditional
Préime DermaFacial (MicroT) K243072 · Stimulator, Transcutaneous Electrical, Aesthetic Purposes	EMA Aesthetics , Ltd. Dublin 2	Class 2	Neurology	1 Apr 2025 Traditional
VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System K242893 · Catheter, Ultrasound, Intravascular	Luma Vision Limited Dublin	Class 2	Cardiovascular	24 Mar 2025 Traditional
pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device K242676 · Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment	Phenox Limited Galway	Class 2	Neurology	28 Feb 2025 Special
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set K250012 · Catheter, Thrombus Retriever	Perfuze, Ltd. Galway	Class 2	Cardiovascular	26 Feb 2025 Special
Calcium2 K244042 · Azo Dye, Calcium	Abbott Ireland Lisnamuck	Class 2	Clinical Chemistry	10 Feb 2025 Traditional
EMPHASYS Acetabular System K243977 · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Depuy Ireland UC Cork	Class 2	Orthopedic	22 Jan 2025 Special
LetsGetChecked Impress K242680 · Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	Privapath Diagnostics Ltd (Dba Letsgetchecked) Dublin	Class 2	General, Plastic Surgery	13 Jan 2025 Traditional
INHANCE INTACT K243248 · Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	23 Dec 2024 Traditional
ATTUNE Revision Hinge Knee K242871 · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	21 Nov 2024 Traditional
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter K242419 · Catheter, Angioplasty, Peripheral, Transluminal	Creagh Medical Ltd. Dba Surmodics, Inc. Ballinasloe	Class 2	Cardiovascular	15 Nov 2024 Traditional
pNOVUS 21 Microcatheter K242420 · Catheter, Intravascular, Diagnostic	Phenox, Ltd. Galway	Class 2	Cardiovascular	12 Nov 2024 Traditional
Zipline Access Catheter K240711 · Catheter, Percutaneous, Neurovasculature	Perfuze, Ltd. Galway	Class 2	Cardiovascular	17 Oct 2024 Traditional
EMPHASYS Acetabular Shell with RapiTite HA K242084 · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Depuy Ireland UC Cork	Class 2	Orthopedic	7 Oct 2024 Traditional
Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set K242504 · Catheter, Thrombus Retriever	Perfuze, Ltd. Galway	Class 2	Cardiovascular	20 Sep 2024 Special
Grass® MR Conditional/CT Cup Electrodes K242346 · Electrode, Cutaneous	Natus Manufacturing Limited Gort	Class 2	Neurology	29 Aug 2024 Traditional
EchoTip AcuCore EUS Biopsy Needle (ECHO-BX-19) K241209 · Biopsy Needle	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	29 Jul 2024 Traditional
GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US) K241887 · Gastrointesinal Lesion Software Detection System	Cosmo Artificial Intelligence - Ai, Ltd. Dublin	Class 2	Gastroenterology, Urology	25 Jul 2024 Special
CM00622 LINC Skin Closure System (CM00622 LINC) K233460 · Cutaneous Tissue Adhesive With Mesh	Connexicon Medical , Ltd. Dublin	Class 2	General, Plastic Surgery	15 Jul 2024 Traditional
CM005 Standard (CM005); CM004 Mini (CM004) K233458 · Tissue Adhesive For The Topical Approximation Of Skin	Connexicon Medical , Ltd. Dublin	Class 2	General, Plastic Surgery	15 Jul 2024 Traditional
ATTUNE Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM NOILES Rotating Hinge Knee System; DePuy P.F.C. SIGMA Total Knee System; DePuy SIGMA Total Knee System; K241000 · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Depuy Ireland UC Ringaskiddy, Co. Cork	Class 2	Orthopedic	11 Jul 2024 Traditional
BioHealx Anal Fistula Device DEN240007 · Anal Fistula Closure Device	Signum Surgical Limited Galway	Class 2	General, Plastic Surgery	1 Jul 2024 Direct
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology K240678 · Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Depuy Ireland UC Cork	Class 2	Orthopedic	18 Jun 2024 Traditional
Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF) K233079 · Stents, Drains And Dilators For The Biliary Ducts	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	14 Jun 2024 Traditional
VELYS Robotic-Assisted Solution K240211 · Orthopedic Stereotaxic Instrument	Depuy Ireland UC Ringaskiddy, Co. Cork	Class 2	Neurology	5 Jun 2024 Traditional
Solo+ Tympanostomy Tube Device (TTD) K232702 · Tube, Tympanostomy	Aventamed Dac Bishopstown	Class 2	Ear, Nose, Throat	20 May 2024 Traditional
Aerogen®Solo Nebulizer System K232507 · Nebulizer (Direct Patient Interface)	Aerogen, Ltd. Dangan Galway	Class 2	Anesthesiology	10 May 2024 Traditional
EVA15 insufflator K232902 · Insufflator, Laparoscopic	Palliare , Ltd. Galway	Class 2	Obstetrics/Gynecology	2 May 2024 Traditional
EMBOGUARD Balloon Guide Catheter K233924 · Catheter, Percutaneous, Neurovasculature	Neuravi Limited Galway	Class 2	Cardiovascular	18 Apr 2024 Special
Mobility+ Enteral Feeding System OTC K233034 · Gastrointestinal Tubes With Enteral Specific Connectors	Rockfield Medical Galway	Class 2	Gastroenterology, Urology	12 Apr 2024 Traditional
Vertex Hip Fracture Nailing System K233910 · Rod, Fixation, Intramedullary And Accessories	Orthoxel Dac Cork	Class 2	Orthopedic	4 Apr 2024 Traditional
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System K233980 · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	21 Mar 2024 Traditional
EMPHASYS Dual Mobility System K231522 · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Depuy Ireland UC Cork Munster	Class 2	Orthopedic	15 Feb 2024 Traditional
DePuy SUMMIT Porocoat Hip Prosthesis MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis MR Conditional K231873 · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	19 Jan 2024 Traditional
GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US) K233964 · Gastrointesinal Lesion Software Detection System	Cosmo Artificial Intelligence - Ai, Ltd. Dublin	Class 2	Gastroenterology, Urology	12 Jan 2024 Special
CORAIL Cemented Femoral Stem K231526 · Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	Depuy Ireland UC Co. Cork	Class 2	Orthopedic	19 Dec 2023 Traditional
Millipede 088 Access Catheter K233648 · Catheter, Percutaneous, Neurovasculature	Perfuze, Ltd. Galway	Class 2	Cardiovascular	14 Dec 2023 Special
VELYS Robotic-Assisted Solution K233227 · Orthopedic Stereotaxic Instrument	Depuy Ireland UC Ringaskiddy, Co. Cork	Class 2	Neurology	14 Dec 2023 Special
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology K232303 · Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	11 Dec 2023 Traditional
Simple 2 Test DEN200070 · System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home	Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) Dun Laoghaire	Class 2	Microbiology	15 Nov 2023 Direct
INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid K230831 · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	13 Nov 2023 Traditional
BeneHold Surgical Incise Drape with CHG antimicrobial II K230645 · Drape, Surgical, Antimicrobial	Avery Dennison Medical , Ltd. Longford	Class 2	General, Plastic Surgery	25 Oct 2023 Traditional
pRESET LITE Thrombectomy Device K231539 · Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment	Phenox Limited Galway	Class 2	Neurology	21 Oct 2023 Traditional
Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set K232524 · Catheter, Thrombus Retriever	Perfuze, Ltd. Galway	Class 2	Cardiovascular	18 Oct 2023 Traditional
EMPHASYS Femoral Stems K233233 · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Depuy Ireland UC Cork	Class 2	Orthopedic	11 Oct 2023 Special
Guardenia (GAR-1) K232701 · Laparoscope, General & Plastic Surgery	Advanced Surgical Concepts Bray	Class 2	Gastroenterology, Urology	29 Sep 2023 Special
DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System K232556 · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Depuy Ireland UC Cork	Class 2	Orthopedic	20 Sep 2023 Special
Millipede 088 Access Catheter K231802 · Catheter, Percutaneous, Neurovasculature	Perfuze, Ltd. Dangan	Class 2	Cardiovascular	19 Sep 2023 Special
Catalyst Bone Void Filler K232315 · Filler, Bone Void, Calcium Compound	Ossdsign AB Uppsala	Class 2	Orthopedic	15 Sep 2023 Traditional
Alkaline Phosphatase2 K223317 · Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Abbott Ireland Diagnostics Division Longsford	Class 2	Clinical Chemistry	21 Jul 2023 Traditional
INHANCE Shoulder System, Sterile Single Use Instrumentation K231516 · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	21 Jul 2023 Traditional
EchoTip® AcuCore Ultrasound Biopsy Needle (ECHO-BX-3-22) K230909 · Biopsy Needle	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	30 May 2023 Traditional
Model 9160 VitaloQUB K223818 · Plethysmograph, Volume	Vitalograph Ireland, Ltd. Ennis Co Clare	Class 2	Anesthesiology	25 May 2023 Traditional
GI Genius System 100 and GI Genius System 200 K231143 · Gastrointesinal Lesion Software Detection System	Cosmo Artificial Intelligence - Ai, Ltd. Dublin	Class 2	Gastroenterology, Urology	19 May 2023 Special
Cumulus Functional Neurophysiology Platform K221963 · Full-Montage Standard Electroencephalograph	Cumulus Neuroscience Limited Belfast	Class 2	Neurology	27 Apr 2023 Traditional
EVA5 Insufflator K230474 · Insufflator, Automatic Carbon-Dioxide For Endoscope	Palliare , Ltd. Galway	Class 2	Gastroenterology, Urology	24 Mar 2023 Special
Arise UHP Dilatation Catheter K230191 · Catheter, Angioplasty, Peripheral, Transluminal	Creagh Medical, Ltd. Ballinasloe	Class 2	Cardiovascular	22 Mar 2023 Traditional
ATTUNE® Revision Cones K230295 · Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Depuy Ireland UC Cork	Class 2	Orthopedic	10 Mar 2023 Traditional
Pro-X1 Trochanteric Nailing System K221621 · Rod, Fixation, Intramedullary And Accessories	X-Bolt Orthopedics Santry	Class 2	Orthopedic	6 Mar 2023 Traditional
Lenire Tinnitus Treatment Device DEN210033 · Combined Acoustic And Electrical External Stimulation Device For The Relief Of Tinnitus	Neuromod Devices Limited Dublin 8	Class 2	Ear, Nose, Throat	6 Mar 2023 Direct
Pill Sense System DEN220065 · Blood Detection Capsule	Enterasense , Ltd. Galway	Class 2	Gastroenterology, Urology	24 Feb 2023 Direct
EVA15 insufflator K222901 · Insufflator, Laparoscopic	Palliare , Ltd. Galway	Class 2	Obstetrics/Gynecology	27 Jan 2023 Traditional
pRESET Thrombectomy Device K222848 · Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment	Phenox Limited Galway	Class 2	Neurology	20 Jan 2023 Traditional
ARTICUL/EZE Ceramic Heads K222296 · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Depuy Ireland UC Cork	Class 2	Orthopedic	6 Jan 2023 Traditional
Total Bilirubin2 K223324 · Diazo Colorimetry, Bilirubin	Abbott Ireland Diagnostics Division Longsford	Class 2	Clinical Chemistry	29 Dec 2022 Traditional
INHANCETM Shoulder System Humeral Stems and Stemless K223211 · Shoulder Prosthesis, Reverse Configuration	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	2 Dec 2022 Traditional
pNOVUS 21 Microcatheter K221279 · Catheter, Intravascular, Diagnostic	Phenox, Ltd. Galway	Class 2	Cardiovascular	28 Nov 2022 Traditional
Mobility+ Enteral Feeding System K222678 · Gastrointestinal Tubes With Enteral Specific Connectors	Rockfield Medical Galway	Class 2	Gastroenterology, Urology	27 Oct 2022 Traditional
NEUROMARK System K222032 · Electrosurgical, Cutting & Coagulation & Accessories	Neurent Medical Galway	Class 2	General, Plastic Surgery	26 Oct 2022 Traditional
DePuy Reclaim Monobloc Revision Femoral Stem K221462 · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Depuy Ireland UC Loughbeg	Class 2	Orthopedic	21 Oct 2022 Traditional
ATTUNE Revision Cones K212746 · Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	17 Oct 2022 Traditional
RespiraSense K220111 · Monitor, Breathing Frequency	Pmd Solutions Cork	Class 2	Anesthesiology	7 Oct 2022 Traditional
Millipede 088 Access Catheter K214048 · Catheter, Percutaneous, Neurovasculature	Perfuze, Ltd. Galway	Class 2	Cardiovascular	20 Sep 2022 Traditional
Soundly Anti Snoring Device K220330 · Device, Anti-Snoring	Greystone Ip, Ltd. Belfast	Class 2	Dental	8 Sep 2022 Abbreviated
EMPHASYS Acetabular System K221636 · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	6 Sep 2022 Traditional
INHANCETM Reverse Glenoid Peripheral Posts K221467 · Shoulder Prosthesis, Reverse Configuration	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	31 Aug 2022 Traditional
C-Stem AMT LE Prosthesis K220216 · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Depuy Ireland UC Cork	Class 2	Orthopedic	22 Jul 2022 Traditional
Model 9100 PFT/DICO K221030 · Calculator, Predicted Values, Pulmonary Function	Vitalograph Ireland, Ltd. Ennis Co Clare	Class 2	Anesthesiology	15 Jul 2022 Traditional
Cholesterol2 K203597 · Enzymatic Esterase--Oxidase, Cholesterol	Abbott Ireland Diagnostics Division Longford	Class 1	Clinical Chemistry	30 Jun 2022 Traditional
INHANCETM Hybrid Anatomic Glenoid Implant K212933 · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	8 Jun 2022 Traditional
Boss Crossing Support Catheter K220632 · Catheter, Percutaneous	Marvao Medical Devices, Ltd. Galway	Class 2	Cardiovascular	2 Jun 2022 Traditional
Urea Nitrogen2 K203771 · Urease And Glutamic Dehydrogenase, Urea Nitrogen	Abbott Ireland Diagnostics Division Longford	Class 2	Clinical Chemistry	31 May 2022 Traditional
Amylase2 K210633 · Catalytic Methods, Amylase	Abbott Ireland Diagnostics Division Longsford	Class 2	Clinical Chemistry	26 May 2022 Traditional
Compass BDS Biliary Stent K213946 · Stents, Drains And Dilators For The Biliary Ducts	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	9 May 2022 Traditional
INHANCE Reverse Shoulder System K212737 · Shoulder Prosthesis, Reverse Configuration	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	21 Apr 2022 Traditional
Emerge Monorail PTCA Dilatation Catheter K220629 · Catheters, Transluminal Coronary Angioplasty, Percutaneous	Boston Scientific Galway	Class 2	Cardiovascular	24 Mar 2022 Special
Creatinine2 K210452 · Alkaline Picrate, Colorimetry, Creatinine	Abbott Ireland Diagnostics Division Longford	Class 2	Clinical Chemistry	22 Mar 2022 Traditional
Albumin BCP2 K203530 · Bromcresol Purple Dye-Binding, Albumin	Abbott Ireland Diagnostics Division Longford	Class 2	Clinical Chemistry	18 Mar 2022 Traditional
Vitalograph Model 6000 Alpha K212938 · Spirometer, Diagnostic	Vitalograph Ireland, Ltd. Ennis Co Clare	Class 2	Anesthesiology	26 Jan 2022 Traditional
GLOBAL ICON Stemless Shoulder System K212683 · Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained	Depuy(Ireland) Cork	Class 2	Orthopedic	19 Jan 2022 Traditional
ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM 3DP K213781 · Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	18 Jan 2022 Special
EMBOGUARD Balloon Guide Catheter K212340 · Catheter, Percutaneous, Neurovasculature	Neuravi Limited Galway	Class 2	Cardiovascular	17 Dec 2021 Traditional
Albumin BCG2 K203248 · Bromcresol Green Dye-Binding, Albumin	Abbott Ireland Diagnostics Division Longford	Class 2	Clinical Chemistry	23 Nov 2021 Traditional
Neuromark System K212666 · Electrosurgical, Cutting & Coagulation & Accessories	Neurent Medical Galway	Class 2	General, Plastic Surgery	22 Oct 2021 Traditional
EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device K212908 · Catheter, Thrombus Retriever	Neuravi, Ltd. Galway	Class 2	Cardiovascular	13 Oct 2021 Special
Halo One Thin-Walled Guiding Sheath K212708 · Introducer, Catheter	C.R. Bard, Inc. Enniscorthy	Class 2	Cardiovascular	23 Sep 2021 Special
RedEx K211234 · Laparoscope, General & Plastic Surgery	Advanced Surgical Concepts, Ltd. Bray	Class 2	Gastroenterology, Urology	17 Sep 2021 Traditional
GLOBAL UNITE Platform Shoulder System K212710 · Shoulder Prosthesis, Reverse Configuration	Depuy Ireland UC Cork	Class 2	Orthopedic	15 Sep 2021 Special
ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert K211609 · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	25 Aug 2021 Traditional
EMPHASYS Femoral Stems K211657 · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Depuy Ireland UC Loughbeg	Class 2	Orthopedic	5 Aug 2021 Traditional
EMBOTRAP III Revascularization Device K211338 · Catheter, Thrombus Retriever	Neuravi, Ltd. Galway	Class 2	Cardiovascular	30 Jul 2021 Traditional
GI Genius K211951 · Gastrointesinal Lesion Software Detection System	Cosmo Artificial Intelligence - Ai, Ltd. Dublin	Class 2	Gastroenterology, Urology	23 Jul 2021 Special
DELTA XTEND Reverse Shoulder System K203694 · Shoulder Prosthesis, Reverse Configuration	Depuy Ireland UC Cork	Class 2	Orthopedic	22 Jul 2021 Traditional
END 200 Endoscopic Tubeset K202922 · Insufflator, Automatic Carbon-Dioxide For Endoscope	Palliare , Ltd. Galway	Class 2	Gastroenterology, Urology	8 Jul 2021 Traditional
Sublime Radial Access 018 RX Dilatation Catheter K211044 · Catheter, Angioplasty, Peripheral, Transluminal	Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics, Ballinasloe	Class 2	Cardiovascular	16 Jun 2021 Special
EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle K210476 · Biopsy Needle	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	20 May 2021 Traditional
Actis DuoFix Hip Prosthesis- Collarless K210581 · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	20 May 2021 Traditional
BI-MENTUM ALTRX® Dual Mobility Liner K203532 · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Depuy Ireland UC Cork	Class 2	Orthopedic	28 Apr 2021 Traditional
GI Genius DEN200055 · Gastrointesinal Lesion Software Detection System	Cosmo Artificial Intelligence - Ai, Ltd. Dublin	Class 2	Gastroenterology, Urology	9 Apr 2021 Direct
SLENDERTONE Evolve Abs, Type 735 K203513 · Stimulator, Muscle, Powered, For Muscle Conditioning	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	10 Feb 2021 Special
VELYS Robotic-Assisted Solution K202769 · Orthopedic Stereotaxic Instrument	Depuy Ireland UC Ringaskiddy, Co. Cork	Class 2	Neurology	14 Jan 2021 Traditional
Attune Revision Sleeve LPS Femoral Adaptors K202248 · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Depuy Ireland UC Cork	Class 2	Orthopedic	28 Dec 2020 Traditional
ReVene Thrombectomy Catheter K201705 · Peripheral Mechanical Thrombectomy With Aspiration	Vetex Medical, Ltd. Galway	Class 2	Cardiovascular	22 Dec 2020 Traditional
GLOBAL UNITE Platform Shoulder System K202098 · Shoulder Prosthesis, Reverse Configuration	Depuy Ireland UC Cork	Class 2	Orthopedic	25 Nov 2020 Traditional
ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology K202194 · Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Depuy Ireland UC Cork	Class 2	Orthopedic	25 Nov 2020 Traditional
EVA15 K202799 · Insufflator, Laparoscopic	Palliare , Ltd. Galway	Class 2	Obstetrics/Gynecology	21 Oct 2020 Special
Spirotrac K201562 · Spirometer, Diagnostic	Vitalograph Ireland, Ltd. Ennis Co Clare	Class 2	Anesthesiology	14 Oct 2020 Traditional
Merit Hydrophilic Guide Wire K201595 · Wire, Guide, Catheter	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	14 Oct 2020 Traditional
DePuy PINNACLE Dual Mobility Liner K200854 · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Depuy Ireland UC Cork	Class 2	Orthopedic	11 Sep 2020 Traditional
Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter K192712 · Catheter, Percutaneous	Medtronic, Inc. Galway	Class 2	Cardiovascular	3 Aug 2020 Traditional
Vitalograph Model 2120 In2itive eDiary K200550 · Spirometer, Diagnostic	Vitalograph Ireland, Ltd. Ennis Co Clare	Class 2	Anesthesiology	27 Jul 2020 Traditional
EVA 15 Insufflator K193520 · Insufflator, Laparoscopic	Palliare , Ltd. Galway	Class 2	Obstetrics/Gynecology	23 Jul 2020 Traditional
EMBOTRAP III Revascularization Device K193063 · Catheter, Thrombus Retriever	Neuravi, Ltd. Galway	Class 2	Cardiovascular	14 Jul 2020 Traditional
Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter K200700 · Catheter, Angioplasty, Peripheral, Transluminal	Creagh Medical, Ltd. Ballinasloe	Class 2	Cardiovascular	14 May 2020 Traditional
SIGMA High Performance (HP) Partial Knee System K193549 · Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	16 Apr 2020 Traditional
Go2Wire Guide Wire K193571 · Wire, Guide, Catheter	Merit Medical System, Inc. Galway	Class 2	Cardiovascular	8 Apr 2020 Traditional
PneumoLiner K192898 · Containment System, Laparoscopic Power Morcellation, With Instrument Port	Advanced Surgical Concepts Bray	Class 2	Obstetrics/Gynecology	25 Feb 2020 Traditional
DELTA XTEND(TM) Reverse Shoulder System K192855 · Shoulder Prosthesis, Reverse Configuration	Depuy(Ireland) Co. Cork	Class 2	Orthopedic	24 Feb 2020 Traditional
The Caterpillar and Caterpillar Micro Arterial Embolization Devices K191532 · Device, Vascular, For Promoting Embolization	C.R. Bard, Inc. Enniscorthy	Class 2	Cardiovascular	4 Feb 2020 Traditional
ATTUNE All-Polyethylene Tibia K193057 · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	30 Jan 2020 Traditional
Merit ONE Snare System K193507 · Device, Percutaneous Retrieval	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	17 Jan 2020 Special
INNOVO K192357 · Cutaneous Electrode Stimulator For Urinary Incontinence	Atlantic Therapeutics, Ltd. Galway	Class 2	Gastroenterology, Urology	16 Jan 2020 Traditional
Halo One Thin-Walled Guiding Sheath K192313 · Introducer, Catheter	C.R. Bard, Inc. Enniscorthy	Class 2	Cardiovascular	19 Dec 2019 Traditional
Advocate PTA Catheter K192907 · Catheter, Angioplasty, Peripheral, Transluminal	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	26 Nov 2019 Traditional
EchoTip Insight Portosystemic Pressure Gradient Measuring System DEN180062 · Endoscopic Transhepatic Venous Access Needle	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	20 Nov 2019 Direct
DePuy Corail AMT Hip Prosthesis K190344 · Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Depuy(Ireland) Cork	Class 2	Orthopedic	1 Nov 2019 Traditional
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire K191687 · Wire, Guide, Catheter	Phenox Limited Galway	Class 2	Cardiovascular	9 Oct 2019 Traditional
Attune Revision LPS Inserts K191779 · Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	Depuy(Ireland) Cork	Class 2	Orthopedic	8 Oct 2019 Traditional
Delta Xtend Revers Shoulder System K192448 · Shoulder Prosthesis, Reverse Configuration	Depuy(Ireland) Cork	Class 2	Orthopedic	4 Oct 2019 Special
BionicGym Powered Muscle Stimulator K182794 · Stimulator, Muscle, Powered, For Muscle Conditioning	Medical Currents, Ltd. Dublin 2	Class 2	Physical Medicine	18 Jul 2019 Traditional
EntericBio Dx Assay K182703 · Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System	Serosep , Ltd. Annacotty	Class 2	Microbiology	19 Jun 2019 Traditional
Delta Xtend Reverse Shoulder System K183077 · Shoulder Prosthesis, Reverse Configuration	Depuy(Ireland) Cork	Class 2	Orthopedic	17 May 2019 Traditional
Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J K182457 · Wire, Guide, Catheter	Brivant Limited (Lake Region Medical) Galway	Class 2	Cardiovascular	18 Apr 2019 Traditional
Telescope Guide Extension Catheter K183353 · Catheter, Percutaneous	Medtronic, Inc. Galway	Class 2	Cardiovascular	22 Mar 2019 Traditional
SelectSite C304-HIS Deflectable Catheter System K183493 · Catheter, Percutaneous	Medtronic, Inc. Galway	Class 2	Cardiovascular	15 Mar 2019 Traditional
EndoFLIP System K183072 · System, Gastrointestinal Motility (Electrical)	Crospon, Ltd. Galway	Class 2	Gastroenterology, Urology	15 Feb 2019 Traditional
HbA1c Advanced K182651 · Hemoglobin A1c Test System	Beckman Coulter Ireland, Inc. O'callaghan's Mills	Class 2	Clinical Chemistry	16 Jan 2019 Traditional
Zilver 518 Biliary Stent, Zilver 635 Biliary Stent K182980 · Stents, Drains And Dilators For The Biliary Ducts	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	16 Nov 2018 Special
neoClose PDS K173917 · Laparoscope, General & Plastic Surgery	Neosurgical, Ltd. Galway	Class 2	Gastroenterology, Urology	8 Nov 2018 Traditional
Innovo DEN170049 · Cutaneous Electrode Stimulator For Urinary Incontinence	Bio-Medical Research, Ltd. Galway	Class 2	Gastroenterology, Urology	6 Nov 2018 Direct
SLENDERTONE CoreFit Abs 8, Type 734 K180688 · Stimulator, Muscle, Powered, For Muscle Conditioning	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	25 Oct 2018 Traditional
X-BOLT Hip Fracture Fixation System K181640 · Rod, Fixation, Intramedullary And Accessories	X-Bolt Orthopaedics Dublin	Class 2	Orthopedic	12 Oct 2018 Traditional
Apex Femoral Nailing System K181375 · Rod, Fixation, Intramedullary And Accessories	Orthoxel Bishopstown	Class 2	Orthopedic	17 Jul 2018 Traditional
Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set K180868 · Stents, Drains And Dilators For The Biliary Ducts	Cook Ireland Limerick	Class 2	Gastroenterology, Urology	6 Jul 2018 Traditional
Allergan Botox Needle Electrode K173815 · Electrode, Needle, Diagnostic Electromyograph	Natus Manufacturing Limited Gort	Class 2	Physical Medicine	29 Jun 2018 Traditional
Sentry IVC Filter K181202 · Filter, Intravascular, Cardiovascular	Novate Medical , Ltd. Galway	Class 2	Cardiovascular	6 Jun 2018 Special
HealthBeacon HB2 Sharps Bin K172719 · Container, Sharps	Healthbeacon, Ltd. Dublin	Class 2	General Hospital	11 May 2018 Traditional
EmboTrap ll Revascularization Device K173452 · Catheter, Thrombus Retriever	Neuravi, Ltd. Galway	Class 2	Cardiovascular	9 May 2018 Traditional
Medtronic Confida Brecker Guidewire K181001 · Wire, Guide, Catheter	Medtronic Core Valve, LLC Galway	Class 2	Cardiovascular	3 May 2018 Traditional
VitaMESH Macroporous PP Surgical Mesh K172636 · Mesh, Surgical, Polymeric	Proxy Biomedical , Ltd. Galway	Class 2	General, Plastic Surgery	30 Apr 2018 Traditional
018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter K180007 · Catheter, Angioplasty, Peripheral, Transluminal	Creagh Medical, Ltd. Ballinasloe	Class 2	Cardiovascular	19 Apr 2018 Traditional
Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set K172057 · Stents, Drains And Dilators For The Biliary Ducts	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	9 Mar 2018 Traditional
Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S K172044 · Stents, Drains And Dilators For The Biliary Ducts	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	27 Feb 2018 Traditional
Sentry IVC Filter K173236 · Filter, Intravascular, Cardiovascular	Novate Medical , Ltd. Galway	Class 2	Cardiovascular	22 Feb 2018 Traditional
NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm) K173805 · Catheter, Hemodialysis, Implanted	Marvao Medical Devices, Ltd. Galway	Class 2	Gastroenterology, Urology	8 Feb 2018 Traditional
GLOBAL UNITE Platform Shoulder System K170748 · Shoulder Prosthesis, Reverse Configuration	Depuy Ireland UC Ringaskiddy	Class 2	Orthopedic	11 Jan 2018 Traditional
Attain Assist CS Access Catheter K171819 · Catheter, Percutaneous	Creganna Medical Also Doing Business AS Ceganna Tactx Medica Galway	Class 2	Cardiovascular	4 Jan 2018 Traditional
Apex Tibial Nailing System K170972 · Rod, Fixation, Intramedullary And Accessories	Orthoxel Bishopstown	Class 2	Orthopedic	20 Dec 2017 Traditional
ContainOR DEN170075 · General Laparoscopic Power Morcellation Containment System	Advanced Surgical Concepts, Ltd. Bray	Class 2	General, Plastic Surgery	19 Dec 2017 Direct
Advocate PTA Catheter K173621 · Catheter, Angioplasty, Peripheral, Transluminal	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	13 Dec 2017 Traditional
NexSite HD, Hemodialysis Step Tip Catheter (60cm) K171571 · Catheter, Hemodialysis, Implanted	Marvao Medical Devices, Ltd. Galway	Class 2	Gastroenterology, Urology	30 Nov 2017 Special
EsoFLIP® ES-310 Balloon Catheter K172128 · Esophageal Dilator With Balloon And Electrode Sensors	Crospon, Ltd. Galway	Class 2	Gastroenterology, Urology	22 Nov 2017 Traditional
014 Hydrophilic Coated PTA Balloon Dilatation Catheter K171251 · Catheter, Angioplasty, Peripheral, Transluminal	Creagh Medical Ballinasloe	Class 2	Cardiovascular	8 Sep 2017 Traditional
Pirouette High Pressure (HP) K172033 · Catheter, Angioplasty, Peripheral, Transluminal	Arravasc, Ltd. Galway	Class 2	Cardiovascular	31 Aug 2017 Traditional
14Fr Colon Decompression Set, Macon Colon Decompression Set K171619 · Tube, Double Lumen For Intestinal Decompression And/Or Intubation	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	1 Aug 2017 Traditional
Nasal Pancreatic Drainage Set K171623 · Stents, Drains And Dilators For The Biliary Ducts	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	31 Jul 2017 Traditional
True Form Reshapable Guide Wire K170532 · Wire, Guide, Catheter	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	21 Jul 2017 Traditional
Merit Hydrophilic Guide Wire K170933 · Wire, Guide, Catheter	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	22 Jun 2017 Special
ATTUNE Cemented Tibial Base, Fixed Bearing K170806 · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Depuy(Ireland) Cork	Class 2	Orthopedic	15 Jun 2017 Traditional
PolyDev Soft Contact Lenses K171157 · Lenses, Soft Contact, Daily Wear	Polydev , Ltd. Collon	Class 2	Ophthalmic	2 Jun 2017 Traditional
Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered K163468 · Stent, Metallic, Expandable, Duodenal	Cook Ireland, Ltd. Limerick	Class 2	General, Plastic Surgery	4 May 2017 Traditional
EndoFLIP® System with FLIP Topography module K170833 · System, Gastrointestinal Motility (Electrical)	Crospon, Ltd. Galway	Class 2	Gastroenterology, Urology	17 Apr 2017 Special
Inqwire Diagnostic Guide Wire K170700 · Wire, Guide, Catheter	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	6 Apr 2017 Special
Multichem IA Plus K162530 · Multi-Analyte Controls, All Kinds (Assayed)	Techno-Path Manufacturing Co. Tipperary	Class 1	Clinical Chemistry	31 Mar 2017 Abbreviated
Inqwire Diagnostic Guide Wire K163575 · Wire, Guide, Catheter	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	3 Mar 2017 Special
Myoject Luer Lock Needle Electrode K161430 · Electrode, Needle, Diagnostic Electromyograph	Natus Manufacturing Limited Gort	Class 2	Physical Medicine	2 Mar 2017 Traditional
Sentry IVC filter K162875 · Filter, Intravascular, Cardiovascular	Novate Medical , Ltd. Galway	Class 2	Cardiovascular	17 Feb 2017 Traditional
Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent K163169 · Stents, Drains And Dilators For The Biliary Ducts	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	7 Feb 2017 Traditional
Ceruloplasmin K161508 · Ceruloplasmin, Antigen, Antiserum, Control	Beckman Coulter Ireland, Inc. Co. Clare	Class 2	Immunology	9 Jan 2017 Traditional
Trapper Exchange Device K162253 · Catheter, Percutaneous	Creganna Medical Aslo Business AS Cregganna Tactx Medical Galway	Class 2	Cardiovascular	6 Jan 2017 Traditional
Zilver 635 Biliary Stent K163018 · Stents, Drains And Dilators For The Biliary Ducts	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	23 Dec 2016 Traditional
Evolution Esophageal Stent System Partially Covered K162717 · Prosthesis, Esophageal	Cook Ireland, Ltd. Limerick	Class 2	General, Plastic Surgery	21 Dec 2016 Traditional
Pirouette 014 K162316 · Catheter, Angioplasty, Peripheral, Transluminal	Arravasc, Ltd. Galway	Class 2	Cardiovascular	22 Nov 2016 Special
SLENDERTONE® Connect Abs, Type 570 K161974 · Stimulator, Muscle, Powered, For Muscle Conditioning	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	1 Nov 2016 Special
Multichem A1c K162514 · Single (Specified) Analyte Controls (Assayed And Unassayed)	Technopath Manufacturing Ballina	Class 1	Clinical Chemistry	26 Oct 2016 Abbreviated
ENROUTE 0.014 Guidewire K160643 · Wire, Guide, Catheter	Lake Region Medical Galway	Class 2	Cardiovascular	18 Oct 2016 Traditional
Toricolors (hioxifilcon D) Soft Contact Lenses K161931 · Lenses, Soft Contact, Daily Wear	Polydev , Ltd. Collon	Class 2	Ophthalmic	12 Oct 2016 Traditional
Vitalograph Model 6300 micro K160253 · Spirometer, Diagnostic	Vitalograph (Ireland) , Ltd. Ennis	Class 2	Anesthesiology	26 Aug 2016 Traditional
NexSite HD Hemodialysis Step Tip Catheter For Long Term Use (24 cm, 28 cm, 32 cm, 36 cm, 40 cm, 55 cm) K161026 · Catheter, Hemodialysis, Implanted	Marvao Medical Devices, Ltd. Galway	Class 2	Gastroenterology, Urology	9 Aug 2016 Traditional
Pirouette 035 K161427 · Catheter, Angioplasty, Peripheral, Transluminal	Arravasc Limited Galway	Class 2	Cardiovascular	30 Jul 2016 Special
GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle K152913 · Introducer, Catheter	Creganna Medical Aslo Business AS Cregganna Tactx Medical Galway	Class 2	Cardiovascular	21 Jul 2016 Traditional
ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer K152905 · Continuous Measurement Thermometer	Arc Devices Limited Galway	Class 2	General Hospital	20 Jul 2016 Traditional
DePuy Actis DuoFix Hip Prosthesis K160907 · Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	Depuy(Ireland) Cork	Class 2	Orthopedic	19 Jul 2016 Traditional
PolyDev Soft Contact Lenses K160977 · Lenses, Soft Contact, Daily Wear	Polydev , Ltd. Collon	Class 2	Ophthalmic	13 Jul 2016 Traditional
ATTUNE Revision Knee System K160700 · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Depuy(Ireland) Cork	Class 2	Orthopedic	10 Jun 2016 Traditional
Beta-2-Microglobulin K161297 · System, Test, Beta-2-Microglobulin Immunological	Beckman Coulter Ireland, Inc. Co. Clare	Class 2	Immunology	7 Jun 2016 Special
Halo One Thin-Walled Guiding Sheath K161183 · Introducer, Catheter	C.R. Bard, Inc. Enniscorthy	Class 2	Cardiovascular	3 Jun 2016 Traditional
EndoFLIP K160725 · System, Gastrointestinal Motility (Electrical)	Crospon, Ltd. Galway	Class 2	Gastroenterology, Urology	1 May 2016 Traditional
PneumoLiner DEN150028 · Containment System, Laparoscopic Power Morcellation, With Instrument Port	Advanced Surgical Concepts, Ltd. Bray	Class 2	Obstetrics/Gynecology	7 Apr 2016 Direct
Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle K160229 · Biopsy Needle	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	21 Mar 2016 Traditional
Slendertone connect Abs K151903 · Stimulator, Muscle, Powered, For Muscle Conditioning	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	6 Nov 2015 Traditional
Neon EEG K151576 · Electrode, Cutaneous	Incereb, Ltd. Dublin	Class 2	Neurology	29 Sep 2015 Traditional
SIC 8000 K150852 · Submucosal Injection Agent	Cosmo Technologies, Ltd. Dublin 1	Class 2	Gastroenterology, Urology	3 Sep 2015 Traditional
Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable Concentric Needle Electrodes-37mm, Dantec DCN Disposable Concentric Needle Electrodes-50mm, Dantec DCN Disposable Concentric Needle Electrodes-75mm K143433 · Electrode, Needle, Diagnostic Electromyograph	Natus Manufacturing Limited Gort	Class 2	Physical Medicine	28 Aug 2015 Traditional
Pirouette 018 K151153 · Catheter, Angioplasty, Peripheral, Transluminal	Arravasc Limited Galway	Class 2	Cardiovascular	20 Aug 2015 Traditional
Cathivex ¿GV filter units K143583 · Filter, Infusion Line	Merck Millipore , Ltd. Carrigtwohill	Class 2	General Hospital	11 Aug 2015 Traditional
Aeroneb USB Contoller System K143719 · Nebulizer (Direct Patient Interface)	Aerogen Limited Galway	Class 2	Anesthesiology	10 Jul 2015 Traditional
EN Snare Endovascular Snare System K151497 · Device, Percutaneous Retrieval	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	1 Jul 2015 Special
Vitalograph Model 6600 Compact K142642 · Spirometer, Diagnostic	Vitalograph (Ireland) , Ltd. Ennis	Class 2	Anesthesiology	30 Jun 2015 Traditional
Vitalograph Model 6800 Pneumotrac K142812 · Spirometer, Diagnostic	Vitalograph (Ireland) , Ltd. Ennis	Class 2	Anesthesiology	29 Jun 2015 Traditional
2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter K151253 · Catheter, Percutaneous, Cutting/Scoring	Boston Scientific Limited Galway	Class 2	Cardiovascular	10 Jun 2015 Special
Euphora Rapid Exchange Balloon Dilatation Catheter K143480 · Catheters, Transluminal Coronary Angioplasty, Percutaneous	Medtronic, Inc. Galway	Class 2	Cardiovascular	2 Apr 2015 Traditional
NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm) K143567 · Catheter, Hemodialysis, Implanted	Marvao Medical Devices, Ltd. Galway	Class 2	Gastroenterology, Urology	31 Mar 2015 Traditional
DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS K140881 · Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	Depuy(Ireland) Co. Cork	Class 2	Orthopedic	13 Feb 2015 Traditional
Passage Hemostasis Valve K143429 · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	22 Dec 2014 Special
Echotip Procore HD Ultrasound Biopsy Needle K142688 · Biopsy Needle	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	19 Dec 2014 Traditional
HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE K140536 · Wire, Guide, Catheter	Lake Region Medical Galway	Class 2	Cardiovascular	17 Dec 2014 Traditional
PRELUDE PLASTIC JACKETED GUIDE WIRE K142051 · Wire, Guide, Catheter	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	17 Dec 2014 Traditional
MERIT HYDROPHILIC GUIDEWIRE K141295 · Wire, Guide, Catheter	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	16 Dec 2014 Traditional
ONE Snare Endovascular Microsnare System K142265 · Device, Percutaneous Retrieval	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	13 Nov 2014 Traditional
neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US K142903 · Laparoscope, General & Plastic Surgery	Neosurgical, Ltd. Galway	Class 2	Gastroenterology, Urology	12 Nov 2014 Special
AERONEB SOLO; AERONEB SOLO ADAPTER K133360 · Nebulizer (Direct Patient Interface)	Aerogen, Ltd. Galway	Class 2	Anesthesiology	17 Oct 2014 Traditional
Urine/CSF Albumin, Urine/CSF Albumin Calibrator K142346 · Albumin, Antigen, Antiserum, Control	Beckman Coulter Ireland, Inc. Co. Clare	Class 2	Immunology	15 Oct 2014 Traditional
MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE K140608 · Wire, Guide, Catheter	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	12 Sep 2014 Special
HYDRAVIEW GUIDEWIRE K141831 · Wire, Guide, Catheter	Brivant Limited Galway	Class 2	Cardiovascular	4 Sep 2014 Traditional
VITALOGRAPH MODEL 7000 SPIROTRAC K141546 · Spirometer, Diagnostic	Vitalograph (Ireland) , Ltd. Ennis, Co. Clare	Class 2	Anesthesiology	3 Sep 2014 Traditional
CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE) K140338 · Introducer, Catheter	Creganna-Tactx Medical Galway	Class 2	Cardiovascular	27 Aug 2014 Traditional
NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER K141090 · Catheters, Transluminal Coronary Angioplasty, Percutaneous	Medtronic, Inc. Galway	Class 2	Cardiovascular	15 Aug 2014 Traditional
COLLACARE DENTAL K133290 · Wound Dressing With Animal-Derived Material(S)	Innocoll Pharmaceuticals Athlone, Co. Westmeath	Class U	Unknown	1 May 2014 Traditional
DEPUY GLOBAL UNITE SHOULDER SYSTEM K133834 · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	Depuy(Ireland) Co. Cork	Class 2	Orthopedic	3 Apr 2014 Traditional
INQWIRE DIAGNOSTIC GUIDE WIRE K133230 · Wire, Guide, Catheter	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	12 Dec 2013 Special
NATUS WARMETTE BLANKET AND DUAL CABINETS K132110 · Warmer, Thermal, Infusion Fluid	Natus Nicolet Ireland, Ltd. Gort, County Galway	Class 2	General Hospital	3 Oct 2013 Traditional
MERIT HYDROPHILIC GUIDE WIRE K131710 · Wire, Guide, Catheter	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	29 Jul 2013 Special
NEOCLOSE HASSON, NEOCLOSE UNIVERSAL K131688 · Laparoscope, General & Plastic Surgery	Neosurgical, Ltd. Galway	Class 2	Gastroenterology, Urology	18 Jul 2013 Special
HEARTSINE SAMARITAN PAD 350P K123881 · Automated External Defibrillators (Non-Wearable)	Heartsine Technologies, Inc. Northern	Class 3	Cardiovascular	11 Jul 2013 Traditional
SLEEK OTW PTA CATHETER K130786 · Catheter, Angioplasty, Peripheral, Transluminal	C.R. Bard, Inc. Enniscorthy, Co. Wexford	Class 2	Cardiovascular	3 May 2013 Special
NEOCLOSE HASSON, NEOCLOSE UNIVERSAL K123280 · Laparoscope, General & Plastic Surgery	Neosurgical, Ltd. Galway	Class 2	Gastroenterology, Urology	18 Apr 2013 Traditional
PLASMATRODE SALINE SAFE TUR ELECTRODE K122716 · Electrosurgical, Cutting & Coagulation & Accessories	Cook Ireland, Ltd. Limerick	Class 2	General, Plastic Surgery	17 Apr 2013 Traditional
ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT K123153 · Catheter, Percutaneous	Medtronic, Ireland Galway	Class 2	Cardiovascular	9 Apr 2013 Traditional
MERIT HYDROPHILIC GUIDE WIRE K130588 · Wire, Guide, Catheter	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	5 Apr 2013 Special
EVOLUTION BILIARY STENT SYSTEM K121430 · Stents, Drains And Dilators For The Biliary Ducts	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	1 Mar 2013 Traditional
BLUE STERILE POWDER FREE NITRILE EXAMINATION GLOVE K122727 · Polymer Patient Examination Glove	Northstar Healthcare Holdings Dublin 2	Class 1	General Hospital	22 Feb 2013 Abbreviated
TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O K122788 · Latex Patient Examination Glove	Northstar Healthcare Holdings Dublin 2	Class 1	General Hospital	17 Jan 2013 Traditional
CHARTER GUIDEWIRE K122856 · Wire, Guide, Catheter	Brivant, Ltd. Galway	Class 2	Cardiovascular	17 Oct 2012 Special
BLUE, LATEX POWDER FREE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH PROTEIN LABLING CLAIM (50UG/DM K121926 · Medical Glove, Specialty	Northstar Healthcare Holdings Hamilton, Bermuda	Class 1	General Hospital	20 Sep 2012 Traditional
MERIT HYDROPHILIC GUIDE WIRE K120644 · Wire, Guide, Catheter	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	19 Sep 2012 Traditional
ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES K121947 · Polymer Patient Examination Glove	Northstar Healthcare Holdings Hamilton, Bermuda	Class 1	General Hospital	10 Sep 2012 Traditional
SPIRALE DRUG DELIVERY SYSTEM K111246 · Nebulizer (Direct Patient Interface)	Armstrong Medical , Ltd. Coleraine	Class 2	Anesthesiology	10 Aug 2012 Traditional
BLACK NITRILE POWDER-FREE EXAMINATION GLOVES K121529 · Polymer Patient Examination Glove	Northstar Healthcare Holdings Hamilton, Bermuda	Class 1	General Hospital	12 Jul 2012 Traditional
BLUE POWER FREE NITRILE EXAMINATION GLOVE K121464 · Polymer Patient Examination Glove	Northstar Healthcare Holdings Dublin 2	Class 1	General Hospital	5 Jul 2012 Traditional
UTB BLUE POWDER FREE NITRILE K121506 · Polymer Patient Examination Glove	Northstar Healthcare Holdings Hamilton, Bermuda	Class 1	General Hospital	3 Jul 2012 Traditional
PROCOLL K120339 · Wound Dressing With Animal-Derived Material(S)	Innocoll Pharmaceuticals Athlone, Co. Westmeath	Class U	Unknown	21 Jun 2012 Traditional
EVOLUTION COLONIC STENT SYSTEM K113510 · Stent, Colonic, Metallic, Expandable	Cook Ireland, Ltd. Limerick	Class 2	General, Plastic Surgery	17 May 2012 Traditional
AERONEB PRO K120939 · Nebulizer (Direct Patient Interface)	Aerogen, Ltd. Galway	Class 2	Anesthesiology	26 Apr 2012 Special
VICTORY GUIDEWIRE (32 MODELS) K120137 · Wire, Guide, Catheter	Brivant, Ltd. Galway	Class 2	Cardiovascular	14 Feb 2012 Special
INJEKT CYSTO FLEXIBLE INJECTION NEEDLE K113634 · Endoscopic Injection Needle, Gastroenterology-Urology	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	14 Feb 2012 Special
NEUROTECH RECOVERY K112934 · Electrode, Cutaneous	Bio-Medical Research, Ltd. Galway	Class 2	Neurology	20 Jan 2012 Traditional
NEUROTECH PLUS K112258 · Stimulator, Nerve, Transcutaneous, For Pain Relief	Bio-Medical Research, Ltd. Galway	Class 2	Neurology	9 Jan 2012 Traditional
VITALOGRAPH MODEL 7100 - VITALOJAK K110525 · Recorder, Magnetic Tape, Medical	Vitalograph (Ireland) , Ltd. Ennis, Co. Clare	Class 2	Cardiovascular	23 Nov 2011 Traditional
BMR FACE K103031 · Stimulator, Transcutaneous Electrical, Aesthetic Purposes	Bio-Medical Research, Ltd. Galway	Class 2	Neurology	10 Nov 2011 Traditional
HI TORQUE CONNECT GUIDEWIRE K112381 · Wire, Guide, Catheter	Lake Region Medical Galway	Class 2	Cardiovascular	3 Nov 2011 Traditional
BANTAM CATHETER (280MM BALLOON LENGTHS) K112335 · Catheter, Percutaneous	ClearStream Technologies , Ltd. Wexford	Class 2	Cardiovascular	12 Oct 2011 Traditional
COLLAGEN POWDER K103648 · Wound Dressing With Animal-Derived Material(S)	Innocoll Pharmaceuticals, Ltd. Athlone, Co. Westmeath	Class U	Unknown	14 Sep 2011 Traditional
COLLACARE DENTAL K110388 · Wound Dressing With Animal-Derived Material(S)	Innocoll Pharmaceuticals, Ltd. Athlone, Co. Westmeath	Class U	Unknown	9 Aug 2011 Traditional
KNEEHAB XP K110350 · Stimulator, Nerve, Transcutaneous, For Pain Relief	Bio-Medical Research, Ltd. Galway	Class 2	Neurology	3 Aug 2011 Traditional
SLEEPMINDER BREATHING FREQUENCY INDICATOR K103631 · Monitor, Breathing Frequency	Biancamed Limited Belfield, Dublin	Class 2	Anesthesiology	21 Jul 2011 Traditional
MERIT MARQUIS FLOW SWITCH K110643 · Catheter, Intravascular, Diagnostic	Merit Medical Systems, Inc. Galway	Class 2	Cardiovascular	1 Jul 2011 Traditional
AVIVAFIX CONDUCTIVE GARMENT-KNEE/SHOULDER/UPPER BACK, TYPE 40 K102614 · Electrode, Cutaneous	Bio-Medical Research, Ltd. Galway	Class 2	Neurology	3 Jun 2011 Traditional
CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 K103377 · Wire, Guide, Catheter	Brivant, Ltd. Galway	Class 2	Cardiovascular	18 May 2011 Special
CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S K103635 · Nebulizer (Direct Patient Interface)	Aerogen, Ltd. Galway	Class 2	Anesthesiology	13 May 2011 Special
EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D K101530 · Stent, Metallic, Expandable, Duodenal	Cook Ireland, Ltd. Limerick	Class 2	General, Plastic Surgery	29 Mar 2011 Traditional
DEPUY GLOBAL UNITE SHOULDER SYSTEM K101996 · Shoulder Prosthesis, Reverse Configuration	Depuy(Ireland) Cork	Class 2	Orthopedic	15 Dec 2010 Traditional
SLEEK OTW PTA CATHETERS K102035 · Catheter, Angioplasty, Peripheral, Transluminal	ClearStream Technologies , Ltd. Wexford	Class 2	Cardiovascular	1 Dec 2010 Special
NIVO NEBULIZER SYSTEM K102240 · Nebulizer (Direct Patient Interface)	Aerogen Ireland, Ltd. Galway	Class 2	Anesthesiology	10 Nov 2010 Special
COLLEXA K100574 · Wound Dressing With Animal-Derived Material(S)	Innocoll Pharmaceuticals Athlone, Co. Westmeath	Class U	Unknown	28 Oct 2010 Traditional
VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 K100687 · Spirometer, Diagnostic	Vitalograph (Ireland) , Ltd. Ennis, Co. Clare	Class 2	Anesthesiology	16 Oct 2010 Traditional
CRUISER 18 GUIDEWIRE K102211 · Wire, Guide, Catheter	Brivant, Ltd. Galway	Class 2	Cardiovascular	3 Sep 2010 Special
REEFLEX PTA CATHETER K101361 · Catheter, Angioplasty, Peripheral, Transluminal	ClearStream Technologies , Ltd. Enniscorthy, County Wexford	Class 2	Cardiovascular	4 Aug 2010 Traditional
SLENDERTONE FLEX MAX, MODEL 517 US K100556 · Stimulator, Muscle, Powered, For Muscle Conditioning	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	2 Aug 2010 Traditional
EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E K093619 · Prosthesis, Esophageal	Cook Ireland, Ltd. Limerick	Class 2	General, Plastic Surgery	17 Jun 2010 Traditional
GUARDIAN II NC HEMOSTASIS VALVE K101113 · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Zerusa Limited Galway	Class 2	Cardiovascular	21 May 2010 Special
SLENDERTONE SYSTEM ULTRA MODEL E70/X70 K100320 · Stimulator, Muscle, Powered, For Muscle Conditioning	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	5 May 2010 Special
LITEPAC, MODEL 682 K100490 · Catheter, Angioplasty, Peripheral, Transluminal	ClearStream Technologies , Ltd. Wexford	Class 2	Cardiovascular	16 Mar 2010 Special
3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON K093515 · Wire, Guide, Catheter	Brivant, Ltd. Galway	Class 2	Cardiovascular	16 Feb 2010 Traditional
COLLAGEN SPONGE K092805 · Wound Dressing With Animal-Derived Material(S)	Innocoll Pharmaceuticals Athlone, Co. Westmeath	Class U	Unknown	16 Feb 2010 Traditional
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O K093195 · Biopsy Needle	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	21 Jan 2010 Traditional
KNEEHAB XP CONTROLLER, MODEL 411 K092791 · Stimulator, Muscle, Powered	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	30 Dec 2009 Special
BANTAM,48XXXXXX, 50XXXXXX K093139 · Catheter, Angioplasty, Peripheral, Transluminal	ClearStream Technologies , Ltd. Wexford	Class 2	Cardiovascular	30 Dec 2009 Special
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 K092505 · Ferritin, Antigen, Antiserum, Control	Beckman Coulter, Inc. Co. Clare	Class 2	Immunology	11 Dec 2009 Traditional
MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411 K092793 · Electrode, Cutaneous	Bio-Medical Research, Ltd. Galway	Class 2	Neurology	7 Dec 2009 Traditional
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A K092359 · Biopsy Needle	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	2 Nov 2009 Traditional
GUARDIAN II HEMOSTASIS VALVE K092711 · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Zerusa Limited Galway	Class 2	Cardiovascular	1 Oct 2009 Special
KNEEHAB XP CONDUCTIVE GARMENT, TYPE 411 K083105 · Stimulator, Muscle, Powered	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	24 Jul 2009 Traditional
STREAMER POLYMER GUIDEWIRE K083094 · Wire, Guide, Catheter	Brivant, Ltd. Galway	Class 2	Cardiovascular	7 Jul 2009 Traditional
LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK K091317 · Stimulator, Nerve, Transcutaneous, For Pain Relief	Bio-Medical Research, Ltd. Galway	Class 2	Neurology	25 Jun 2009 Special
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN K081615 · System, Test, Carcinoembryonic Antigen	Olympus America, Inc. Co. Clare	Class 2	Immunology	18 Mar 2009 Traditional
OLYMPUS AFP - ALPHA-FETOPROTEIN K081709 · Kit, Test,Alpha-Fetoprotein For Testicular Cancer	Olympus Life Science Research Europa GmbH (Europa) O'callaghans Mills, Co. Clare	Class 2	Immunology	16 Mar 2009 Traditional
BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298 K082190 · Stimulator, Nerve, Transcutaneous, For Pain Relief	Bio-Medical Research, Ltd. Galway	Class 2	Neurology	11 Mar 2009 Traditional
REEKROSS FAMILY OR OTW PTA CATHETERS K083596 · Catheter, Percutaneous	ClearStream Technologies , Ltd. Wexford	Class 2	Cardiovascular	2 Mar 2009 Traditional
STRYKER DISPOSABLE CRANIAL PERFORATOR BIT K082010 · Drills, Burrs, Trephines & Accessories (Compound, Powered)	Stryker Ireland Ltd., Instruments Division Carrigtwohill, Co.cork	Class 2	Neurology	29 Dec 2008 Traditional
SYSTEM-ARMS, MODELS 390, X60 K083164 · Stimulator, Muscle, Powered, For Muscle Conditioning	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	16 Dec 2008 Special
MEDISTIM XP, TYPE 281 AND MEDITENS XP, TYPE 458 K082011 · Stimulator, Nerve, Transcutaneous, For Pain Relief	Bio-Medical Research, Ltd. Galway	Class 2	Neurology	28 Nov 2008 Traditional
AERONEB GO NEBULIZER K081650 · Nebulizer (Direct Patient Interface)	Aerogen (Ireland), Ltd. Dangan Galway	Class 2	Anesthesiology	23 Oct 2008 Special
COLLIEVA K081782 · Wound Dressing With Animal-Derived Material(S)	Innocoll Pharmaceuticals Athlone, Co. Westmeath	Class U	Unknown	30 Sep 2008 Traditional
STRYKER ESSX MICRODEBRIDER SYSTEM K073633 · Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Stryker Ireland Ltd., Instruments Division Carrigtwohill, Co.cork	Class 2	Ear, Nose, Throat	26 Aug 2008 Traditional
HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM K080966 · Chamber, Oxygen, Topical, Extremity	Aoti , Ltd. Galway	Class 2	General, Plastic Surgery	6 Aug 2008 Traditional
VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6) K073155 · Spirometer, Diagnostic	Vitalograph (Ireland) , Ltd. Ennis, Co. Clare	Class 2	Anesthesiology	4 Jun 2008 Traditional
EVOLUTION ESOPHAGEAL STENT SYSTEM K080359 · Prosthesis, Esophageal	Cook Ireland, Ltd. Limerick	Class 2	General, Plastic Surgery	9 May 2008 Traditional
SLENDERTONE ENERVIVE, MODEL 561 K071666 · Stimulator, Muscle, Powered, For Muscle Conditioning	Bio-Medical Research Corp. Galway	Class 2	Physical Medicine	12 Mar 2008 Traditional
GUARDIAN HEMOSTASIS VALVE K073620 · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Zerusa Limited Galway	Class 2	Cardiovascular	27 Feb 2008 Traditional
OLYMPUS IGM REAGENT K073487 · Method, Nephelometric, Immunoglobulins (G, A, M)	Olympus America, Inc. Co. Clare	Class 2	Immunology	11 Feb 2008 Traditional
OLYMPUS IGG REAGENT K073490 · Method, Nephelometric, Immunoglobulins (G, A, M)	Olympus America, Inc. Co. Clare	Class 2	Immunology	11 Feb 2008 Traditional
OLYMPUS IGA REAGENT K073489 · Method, Nephelometric, Immunoglobulins (G, A, M)	Olympus America, Inc. Co. Clare	Class 2	Immunology	11 Feb 2008 Traditional
CPS COURIER GUIDEWIRE K073082 · Wire, Guide, Catheter	Brivant, Ltd. Galway	Class 2	Cardiovascular	9 Jan 2008 Special
SYSTEM-ARMS, MODEL 390,E60 K072553 · Stimulator, Muscle, Powered, For Muscle Conditioning	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	14 Dec 2007 Traditional
SYSTEM-MINI, MODELS: 390, E30 K072294 · Stimulator, Muscle, Powered, For Muscle Conditioning	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	25 Oct 2007 Special
OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 K070708 · Radioimmunoassay, Free Thyroxine	Olympus Life & Material Science Europa GmbH (Irish Co. Clare	Class 2	Clinical Chemistry	21 Aug 2007 Traditional
OLYMPUS CK-MB REAGENT K070835 · Colorimetric Method, Cpk Or Isoenzymes	Olympus Life & Material Science Europa GmbH (Irish O'callaghans Mills, Co. Clare	Class 2	Clinical Chemistry	4 Jun 2007 Traditional
RESONANCE METALLIC URETERAL STENT K063742 · Stent, Ureteral	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	8 May 2007 Traditional
AERONEB PROFESSIONAL NEBULIZER SYSTEM K070642 · Nebulizer (Direct Patient Interface)	Aerogen (Ireland), Ltd. Dangan Galway	Class 2	Anesthesiology	7 May 2007 Special
SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 K070142 · Stimulator, Muscle, Powered, For Muscle Conditioning	Bio-Medical Research Corp. Galway	Class 2	Physical Medicine	23 Mar 2007 Traditional
COLLAGUARD, MODEL FCIA,FCIB,FCIC,AND FCID K061746 · Wound Dressing With Animal-Derived Material(S)	Innocoll Pharmaceuticals Athlone, Co. Westmeath	Class U	Unknown	2 Oct 2006 Traditional
SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE K060623 · Anoscope And Accessories	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	6 Sep 2006 Traditional
MARATHON STENT WITH FUSION TECHNOLOGY K060624 · Stents, Drains And Dilators For The Biliary Ducts	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	4 Aug 2006 Traditional
EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01 K060289 · Instrument, Manual, Specialized Obstetric-Gynecologic	Frontline Medical Limerick	Class 2	Obstetrics/Gynecology	7 Jul 2006 Traditional
BRIVANT GUIDEWIRE K060551 · Wire, Guide, Catheter	Brivant Limited Oranmore, Galway	Class 2	Cardiovascular	7 Jun 2006 Traditional
BIPAP FOCUS K053168 · Ventilator, Continuous, Non-Life-Supporting	Respironics (Ireland) Limited Galway	Class 2	Anesthesiology	4 Jan 2006 Traditional
GUARDIAN HEMOSTASIS VALVE WITH GUIDEWIRE INTRODUCER K052381 · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Zerusa Limited Galway	Class 2	Cardiovascular	21 Nov 2005 Traditional
SLENDERTONE GYMBODY, MODEL 512-01 K052969 · Stimulator, Muscle, Powered, For Muscle Conditioning	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	16 Nov 2005 Special
COOK IRELAND ECHOBRUSH K052279 · Endoscopic Cytology Brush	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	11 Oct 2005 Traditional
INSPIRATION VENTILATOR SYSTEM K051550 · Ventilator, Continuous, Facility Use	eVent Medical, Ltd. Galway	Class 2	Anesthesiology	12 Jul 2005 Special
COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE K050578 · Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	22 Apr 2005 Traditional
COOK IRELAND SONNET POLYPECTOMY SNARE K050294 · Snare, Flexible	Cook Ireland, Ltd. Limerick	Class 2	Gastroenterology, Urology	31 Mar 2005 Traditional
NEUROTECH KNEEHAB K024258 · Stimulator, Muscle, Powered	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	4 Mar 2005 Traditional
GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM K040862 · Ventilator, Non-Continuous (Respirator)	Caradyne, Ltd. Galway	Class 2	Anesthesiology	30 Jun 2004 Traditional
MEDICAL AIR COMPRESSOR K040220 · Compressor, Air, Portable	eVent Medical, Ltd. Galway	Class 2	Anesthesiology	9 Jun 2004 Traditional
BMR NEUROTECH BACK TENS AND LUMBAR SUPPORT DEVICE. TYPE 294 K023916 · Stimulator, Nerve, Transcutaneous, For Pain Relief	Bio-Medical Research, Ltd. Galway	Class 2	Neurology	15 Apr 2004 Traditional
MODIFICATION TO INSPIRATION VENTILATOR SYSTEM K030341 · Ventilator, Continuous, Facility Use	eVent Medical, Ltd. Galway	Class 2	Anesthesiology	16 Jan 2004 Traditional
NEUROTECH BAXOLVE TYPE 294 K023913 · Stimulator, Nerve, Transcutaneous, For Pain Relief	Bio-Medical Research, Ltd. Galway	Class 2	Neurology	25 Aug 2003 Traditional
SLENDERTONE FLEX ABDOMINAL TRAINING SYSTEM, TYPE 515 K030708 · Stimulator, Muscle, Powered, For Muscle Conditioning	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	25 Jun 2003 Traditional
ANDREWS INTRODUCER, MODEL ASI01 K023173 · Instrument, Manual, Surgical, General Use	Andrews Surgical Innovations, Ltd. Co. Dublin	Class 1	General, Plastic Surgery	18 Dec 2002 Traditional
RANDOX HAEMOGLOBIN A1C K021897 · Assay, Glycosylated Hemoglobin	Randox Laboratories, Ltd. Crumlin	Class 2	Hematology	26 Nov 2002 Traditional
NEUROTECH MEDISTIM PLUS, TYPE 291 K014019 · Stimulator, Muscle, Powered	Bio-Medical Research, Ltd. Galway	Class 2	Physical Medicine	11 Jul 2002 Traditional
NT MEDITENS PLUS, TYPE 290 K014020 · Stimulator, Nerve, Transcutaneous, For Pain Relief	Bio-Medical Research, Ltd. Galway	Class 2	Neurology	11 Jul 2002 Traditional
CAPTIAM SYPHILIS-G ASSAY K014233 · Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Trinity Biotech, Plc Co. Wicklow	Class 2	Microbiology	24 Jan 2002 Special
INVERNESS MEDICAL EARLY PREGNANCY TEST K013907 · Kit, Test, Pregnancy, Hcg, Over The Counter	Cambridge Diagnostics Ireland, Ltd. Galway	Class 2	Clinical Chemistry	18 Dec 2001 Special
RANDOX PHENYTOIN K011393 · Enzyme Immunoassay, Diphenylhydantoin	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 2	Clinical Toxicology	4 Dec 2001 Traditional
UNI-GOLD STREP A TEST KIT K011709 · Antisera, All Groups, Streptococcus Spp.	Trinity Biotech, Plc Ballinasloe	Class 1	Microbiology	8 Nov 2001 Traditional
TELEPRESS III BLOOD PRESSURE MONITOR, MODEL TPIII K011058 · System, Measurement, Blood-Pressure, Non-Invasive	Meridian Medical Technologies , Ltd. Belfast	Class 2	Cardiovascular	23 Oct 2001 Traditional
RANDOX GENTAMICIN K012978 · Enzyme Immunoassay, Gentamicin	Randox Laboratories, Ltd. Crumlin	Class 2	Clinical Toxicology	18 Sep 2001 Traditional
RANDOX DIGOXIN K011302 · Enzyme Immunoassay, Digoxin	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 2	Clinical Toxicology	2 Jul 2001 Traditional
RANDOX PHENOBARBITAL K011303 · Enzyme Immunoassay, Phenobarbital	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 2	Clinical Toxicology	2 Jul 2001 Traditional
BRIDGE III RECEIVER K010794 · Transmitters And Receivers, Electrocardiograph, Telephone	Meridian Medical Technologies , Ltd. Belfast	Class 2	Cardiovascular	10 May 2001 Traditional
RANDOX MYOGLOBIN K010700 · Myoglobin, Antigen, Antiserum, Control	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 2	Immunology	8 May 2001 Traditional
RANDOX TRANSFERRIN K002585 · Transferrin, Antigen, Antiserum, Control	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 2	Immunology	5 Feb 2001 Traditional
CARDIOBEEPER CB12/12, MODEL CB12/12 K002310 · Transmitters And Receivers, Electrocardiograph, Telephone	Meridian Medical Technologies , Ltd. Belfast	Class 2	Cardiovascular	25 Oct 2000 Traditional
RANDOX MICROALBUMIN K002674 · Albumin, Fitc, Antigen, Antiserum, Control	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 2	Immunology	5 Oct 2000 Traditional
RANDOX PREALBUMIN K000661 · Prealbumin, Antigen, Antiserum, Control	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 1	Immunology	13 Apr 2000 Traditional
RANDOX FERRITIN K000662 · Ferritin, Antigen, Antiserum, Control	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 2	Immunology	3 Apr 2000 Traditional
RANDOX ALBUMIN K000483 · Bromcresol Purple Dye-Binding, Albumin	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 2	Clinical Chemistry	31 Mar 2000 Traditional
RANDOX COMPLEMENT C3 K000469 · Complement C3, Antigen, Antiserum, Control	Randox Laboratories, Ltd. Crumlin	Class 2	Immunology	27 Mar 2000 Traditional
NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER K990897 · Nebulizer (Direct Patient Interface)	Puritan-Bennett Ireland, Ltd. Galway	Class 2	Anesthesiology	15 Mar 2000 Traditional
NELLCOR PURITAN BENNETT, 760 VENTILATOR SYSTEM K984379 · Ventilator, Continuous, Facility Use	Puritan Bennett Corp. Galway	Class 2	Anesthesiology	10 Dec 1998 Special
CARDIOBEEPER CB250 K983582 · Transmitters And Receivers, Electrocardiograph, Telephone	Merdian Medical Technologies , Ltd. Antrium	Class 2	Cardiovascular	13 Nov 1998 Traditional
LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) K970761 · Reagent, Borrelia Serological Reagent	Cambridge Diagnostics Ireland, Ltd. Galway	Class 2	Microbiology	9 Apr 1998 Traditional
HUMAN LYME IGM WESTERN BLOT KIT K970768 · Reagent, Borrelia Serological Reagent	Cambridge Diagnostics Ireland, Ltd. Galway	Class 2	Microbiology	9 Apr 1998 Traditional
RANDOX CREATININE K973993 · Alkaline Picrate, Colorimetry, Creatinine	Randox Laboratories, Ltd. Crumlin	Class 2	Clinical Chemistry	6 Mar 1998 Traditional
RANDOX MAGNESIUM K974606 · Photometric Method, Magnesium	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 1	Clinical Chemistry	12 Feb 1998 Traditional
RANDOX CALCIUM K974607 · Azo Dye, Calcium	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 2	Clinical Chemistry	2 Feb 1998 Traditional
RANDOX INORGANIC PHOSPHOROUS K974605 · Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 1	Clinical Chemistry	9 Jan 1998 Traditional
RANDOX IRON K974604 · Ferrozine (Colorimetric) Iron Binding Capacity	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 1	Clinical Chemistry	6 Jan 1998 Traditional
RANDOX BILIRUBIN K973995 · Hemoglobinometer	Randox Laboratories, Ltd. Crumlin	Class 2	Hematology	8 Dec 1997 Traditional
RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT K972220 · System, Test, Rheumatoid Factor	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 2	Immunology	9 Sep 1997 Traditional
RANDOX ASSAYED SPECIFIC PROTEIN CONTROL K972608 · Multi-Analyte Controls, All Kinds (Assayed)	Randox Laboratories, Ltd. Crumlin	Class 1	Clinical Chemistry	4 Aug 1997 Traditional
PANCREATIC AMYLASE, ETHYLIDENE BLOCKED-PNPG7 ENZYME COLORIMETRIC TEST K971825 · Catalytic Methods, Amylase	Randox Laboratories, Ltd. Crumlin	Class 2	Clinical Chemistry	24 Jul 1997 Traditional
BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL K970735 · Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Randox Laboratories, Ltd. Crumlin	Class 1	Clinical Chemistry	6 Jun 1997 Traditional
LACTATE DEHYDROGENASE (LD) K970684 · Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Randox Laboratories, Ltd. Crumlin	Class 2	Clinical Chemistry	7 May 1997 Traditional
GLUCOSE (HEXOKINASE) KIT K953210 · Hexokinase, Glucose	Randox Laboratories, Ltd. Crumlin	Class 2	Clinical Chemistry	25 Oct 1996 Traditional
RHEUMATOID FACTOR LATEX SLIDE TEST KIT K961169 · System, Test, Rheumatoid Factor	Randox Laboratories, Ltd. Crumlin	Class 2	Immunology	26 Jun 1996 Traditional
AMYLASE (ETHYLIDENE PNGPG7) KIT K953211 · Saccharogenic, Amylase	Randox Laboratories, Ltd. Crumlin	Class 2	Clinical Chemistry	21 Jun 1996 Traditional
CALIBRATION SERUM LEVEL 1 & 2 K955489 · Calibrator, Multi-Analyte Mixture	Randox Laboratories, Ltd. Crumlin	Class 2	Clinical Chemistry	21 Jun 1996 Traditional
GASTRIN EIA MODEL 06B-555017 K961276 · Radioimmunoassay, Gastrin	Biosyn , Ltd. Belfast	Class 1	Clinical Chemistry	30 May 1996 Traditional
TOTAL PROTEIN (URINE) K951222 · Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Randox Laboratories, Ltd. Crumlin	Class 1	Clinical Chemistry	24 Apr 1996 Traditional
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR K955798 · Igg, Antigen, Antiserum, Control	Randox Laboratories, Ltd. Crumlin	Class 2	Immunology	5 Apr 1996 Traditional
IGA IMMUNOTURBIDIMETRIC & CALIBRATOR K955794 · Iga, Antigen, Antiserum, Control	Randox Laboratories, Ltd. Crumlin	Class 2	Immunology	5 Apr 1996 Traditional
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR K955797 · Igm, Antigen, Antiserum, Control	Randox Laboratories, Ltd. Crumlin	Class 2	Immunology	5 Apr 1996 Traditional
SELFCARE EARLY PREGNANCY TEST K960436 · Kit, Test, Pregnancy, Hcg, Over The Counter	Selfcare, Inc. Galway	Class 2	Clinical Chemistry	19 Mar 1996 Traditional
SELFCARE EARLY PREGNANCY TEST K955903 · Kit, Test, Pregnancy, Hcg, Over The Counter	Cambridge Diagnostics Ireland, Ltd. Galway	Class 2	Clinical Chemistry	6 Mar 1996 Traditional
CK-MB (NAC-ACT) K951223 · Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Randox Laboratories, Ltd. Crumlin	Class 2	Clinical Chemistry	26 Dec 1995 Traditional
C-REACTIVE PROTEIN LATEX KIT K954447 · C-Reactive Protein, Antigen, Antiserum, And Control	Randox Laboratories, Ltd. Crumlin	Class 2	Immunology	18 Dec 1995 Traditional
APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT K950383 · Turbidimetric Method, Lipoproteins	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 1	Clinical Chemistry	15 Sep 1995 Traditional
APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT K950382 · Turbidimetric Method, Lipoproteins	Randox Laboratories, Ltd. Crumlin, Co. Antrim	Class 1	Clinical Chemistry	15 Sep 1995 Traditional
C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC KIT & CRP CALIBRATOR K953212 · C-Reactive Protein, Antigen, Antiserum, And Control	Randox Laboratories, Ltd. Crumlin	Class 2	Immunology	31 Jul 1995 Traditional
PRECISION-MULTI-SERA - HUMAN - NORMAL AND ELEVATED K942458 · Multi-Analyte Controls, All Kinds (Assayed)	Randox Laboratories, Ltd. Crumlin	Class 1	Clinical Chemistry	13 Mar 1995 Traditional
DUET K934970 · Prosthesis, Adhesive, External	Trulife , Ltd. Dublin 24	Class 1	General, Plastic Surgery	10 Dec 1993 Traditional
ROTO REST; TRAUMA AND INTENSIVE CARE BED K905113 · Bed, Patient Rotation, Powered	Ethos Medical Products , Ltd. Athlone	Class 2	Physical Medicine	26 Nov 1990 Traditional
SHANNON LATEX MEDICAL GLOVES K895804 · Latex Patient Examination Glove	Cashmor Mfg. , Ltd. Longford	Class 1	General Hospital	8 Nov 1989 Traditional
NR5000 E.C.G. AND PULSE OXIMETER MONITOR K894919 · Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Nirad , Ltd. Antrim Co. Antrim	Class 2	Cardiovascular	18 Sep 1989 Traditional
NR2000 CARDIAC MONITOR K883903 · Electrocardiograph	Nirad , Ltd. Antrim Co. Antrim	Class 2	Cardiovascular	9 Mar 1989 Traditional
LITEGUARD 9 K851924 · Dc-Defibrillator, Low-Energy, (Including Paddles)	Temtech , Ltd. Bangot,co. Down Bt192qy	Class 2	Cardiovascular	6 Aug 1985 Traditional
WSP CODE 4300 DIOMASTER DIAGNOSTIC K850696 · Cystometric Gas (Carbon-Dioxide) On Hydraulic Device	Warne Surgical Products, Ltd. Armagh Bt66 8rd	Class 2	Gastroenterology, Urology	17 May 1985 Traditional
WSP CODE 4310 STRESSCATH K850694 · Cystometric Gas (Carbon-Dioxide) On Hydraulic Device	Warne Surgical Products, Ltd. Armagh Bt66 8rd	Class 2	Gastroenterology, Urology	17 May 1985 Traditional
WSP CODE 4301 DIOMASTER THERAPEUTIC K850695 · Cystometric Gas (Carbon-Dioxide) On Hydraulic Device	Warne Surgical Products, Ltd. Armagh Bt66 8rd	Class 2	Gastroenterology, Urology	16 May 1985 Traditional
WSP CODE 4315 PADTEST K850693 · Cystometric Gas (Carbon-Dioxide) On Hydraulic Device	Warne Surgical Products, Ltd. Armagh Bt66 8rd	Class 2	Gastroenterology, Urology	10 May 1985 Traditional

Applicants are listed as registered with the FDA; a company can hold clearances under more than one name. Ireland is determined by the applicant's country in the 510(k) record.

Irish applicants by clearances

Applicant	Clearances	Latest
Depuy Ireland UC Ringaskiddy, Co. Cork	48	25 Jun 2026
Randox Laboratories, Ltd. Crumlin	37	26 Nov 2002
Cook Ireland, Ltd. Limerick	33	24 Jul 2026
Bio-Medical Research, Ltd. Galway	28	10 Feb 2021
Merit Medical Systems, Inc. Galway	19	14 Oct 2020
Depuy(Ireland) Cork	12	19 Jan 2022
Perfuze, Ltd. Galway	11	12 Aug 2026
Abbott Ireland Diagnostics Division Longsford	8	21 Jul 2023
Vitalograph (Ireland) , Ltd. Ennis	7	26 Aug 2016
Northstar Healthcare Holdings Dublin 2	7	22 Feb 2013
Brivant, Ltd. Galway	7	17 Oct 2012
Cosmo Artificial Intelligence - Ai, Ltd. Dublin	6	29 May 2026
Palliare , Ltd. Galway	6	2 May 2024
Innocoll Pharmaceuticals Athlone, Co. Westmeath	6	1 May 2014
ClearStream Technologies , Ltd. Wexford	6	12 Oct 2011

Irish clearances by town

Town	Clearances
Galway	174
Crumlin	37
Limerick	35
Cork	29
Ringaskiddy	27
Dublin	16
Co. Clare	9
Athlone	9
Longford	8
Ballinasloe	7
Ennis	7
Dublin 2	6

All FDA 510(k) clearances, last 90 days

684 decisions

Device	Applicant	Country	Specialty	Decision
Safety lancet (XL) K262526 · Class 2	Tianjin Huahong Technology Co., Ltd.	CN	General, Plastic Surgery	13 Sep 2026
Digistat Care K261287 · Class 2	Ascom Ums Srl Unipersonale	IT	Cardiovascular	12 Sep 2026
CADDIE K260133 · Class 2	Odin Medical Limited	GB	Gastroenterology, Urology	12 Sep 2026
Potenza Prime K254185 · Class 2	Jeisys Medical Incorporated	KR	General, Plastic Surgery	11 Sep 2026
CraniUS Plate K262874 · Class 2	CraniUS, LLC	US	Neurology	11 Sep 2026
Single Use Ureteral Access Sheath K260410 · Class 2	Zhejiang Chuangxiang Medical Technology Co., Ltd.	CN	Gastroenterology, Urology	11 Sep 2026
GSPE Spacer K260063 · Class 2	The General Hospital Corporation, d/b/a Massachusetts	US	Orthopedic	11 Sep 2026
Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF System K262025 · Class 2	INNO Holdings Inc. DBA Innovasis	US	Orthopedic	11 Sep 2026
CuratOR EX2742 K262397 · Class 2	Eizo Corporation	JP	Gastroenterology, Urology	11 Sep 2026
SpaceOAR Flex System K262151 · Class 2	Boston Scientific Corporation	US	Radiology	11 Sep 2026
iLet Dosing Decision Software K262763 · Class 2	Beta Bionics, Inc.	US	Clinical Chemistry	11 Sep 2026
MICSI-PET K261305 · Class 2	Microstructure Imaging, Inc.	US	Radiology	11 Sep 2026
DRIM-Nail System K260115	41Medical AG	CH	Unknown	11 Sep 2026
Extroducer Infusion Catheter System K254051 · Class 2	SmartWise Sweden AB	SE	Cardiovascular	11 Sep 2026
ANTERION K261019 · Class 2	Heidelberg Engineering GmbH	DE	Ophthalmic	11 Sep 2026
Mint ACE Pump K260001 · Class 2	Beta Bionics, Inc.	US	Clinical Chemistry	11 Sep 2026
Ecomed Disposable Administration Sets K254123 · Class 2	Ecomed Solutions, LLC	US	General Hospital	11 Sep 2026
RENASYS DYNAFLOW Kit (66807741) K261338 · Class 2	Smith & Nephew Medical, Ltd.	GB	General, Plastic Surgery	11 Sep 2026
PureLift Pro Max K262861 · Class 2	Xtreem Pulse, LLC	US	Neurology	11 Sep 2026
Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) K254119 · Class 2	Shenzhen Xinyan Medical Technology Co.,ltd.	CN	Cardiovascular	11 Sep 2026
Disposable Sterile Skull Drill (LZ) K254177 · Class 2	Guizhou Zirui Technology Co., Ltd.	CN	Neurology	11 Sep 2026
KOWA FM-600 K261255 · Class 2	Kowa Company, Ltd. Chofu Factory	JP	Ophthalmic	11 Sep 2026
Surgical Power System K254174 · Class 2	Guizhou Zirui Technology Co., Ltd.	CN	Neurology	11 Sep 2026
Venti-Trach Tracheostomy Tube (570 Series); Venti-Trach Tracheostomy Tube (571 Series); Venti-Trach Tracheostomy Tube (580 Series); Venti-Trach Tracheostomy Tube (581 Series) K253063 · Class 2	Vitaltec Corporation	TW	Anesthesiology	11 Sep 2026
Sequential Circulator (SC-4004-DL, SC-4008-DL) K261807 · Class 2	Bio Compression Systems, Inc.	US	Cardiovascular	11 Sep 2026
ZBPro Diagnostic (Version 2.0) K261580 · Class 2	Zbeats, Inc.	US	Cardiovascular	11 Sep 2026
SkinSmart Antimicrobial HydroGel K254041 · Class U	Magic Science Supply, LLC	US	Unknown	11 Sep 2026
FINDER Flu A&B/SARS-CoV-2 Test K261837 · Class 2	Baebies, Inc.	US	Microbiology	11 Sep 2026
PRIMED AAMI Level 3 Open Back Gowns K262007 · Class 2	PRIMED Medical Products, Inc.	CA	General, Plastic Surgery	11 Sep 2026
Mg OSTEOREVIVE;Mg OSTEOCRETE K262230 · Class 2	Bone Solutions, Inc.	US	Orthopedic	11 Sep 2026
Vioseal X K262050 · Class 2	Spident Co., Ltd.	KR	Dental	11 Sep 2026
BoneVue K254072 · Class 2	Curvebeam AI / Curvebeam, LLC	US	Radiology	11 Sep 2026
4K Camera Head OLYMPUS CH-S700-08-LB K262079 · Class 2	Olympus Medical Systems Corp.	JP	Gastroenterology, Urology	10 Sep 2026
Geniant Cranial (Navigated Neurosurgical Positioning Robot) K253856 · Class 2	Koh Young Technology, Inc.	KR	Neurology	10 Sep 2026
EVOLUTION MPX Total Knee System K262293 · Class 2	Suzhou Microport Orthorecon Co., Ltd.	CN	Orthopedic	10 Sep 2026
ACUNAV Luxera 4D ICE Catheter K261696 · Class 2	Siemens Medical Solutions USA, Inc.	US	Cardiovascular	10 Sep 2026
4DM K260879 · Class 2	INVIA, LLC	US	Radiology	10 Sep 2026
TruPress K254074 · Class 2	Procerus Enterprises	US	Cardiovascular	10 Sep 2026
Cerasmart Forte K262202 · Class 2	GC America, Inc.	US	Dental	10 Sep 2026
BioTeke® Multi-Drug Urine Test Cup K261409 · Class 2	Bioteke Corporation (Wuxi) Co., Ltd.	CN	Clinical Toxicology	10 Sep 2026
Diode Laser Therapy System K261562 · Class 2	Sanhe LEFIS Electronics Co., Ltd.	CN	General, Plastic Surgery	10 Sep 2026
Upper Arm Blood pressure monitor (BP7155D) K261929 · Class 2	OMRON Healthcare, Inc.	US	Cardiovascular	10 Sep 2026
Irrigation/Urology Sets K254111 · Class 2	B.Braun Medical, Inc.	US	Gastroenterology, Urology	10 Sep 2026
Quicktome Software Suite K261795 · Class 2	Omniscient Neurotechnology Pty, Ltd.	AU	Radiology	10 Sep 2026
LT Antibacterial Foam with Silver Dressing K254246 · Class 1	Zhejiang Longterm Medical Technology Co., Ltd.	CN	General, Plastic Surgery	10 Sep 2026
Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) K254009	Lakong Medical Devices Co., Ltd.	CN	Dental	10 Sep 2026
Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) K262426 · Class 2	Wuhan Pioon Technology Co., Ltd.	CN	General, Plastic Surgery	10 Sep 2026
danumed Extension Set for Gastrostomy Button K260110 · Class 2	Danumed Medizintechnik GmbH	DE	Gastroenterology, Urology	10 Sep 2026
Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) K261793 · Class 1	Maxter Healthcare, Inc.	US	General Hospital	9 Sep 2026
ChestView US (1.1) K252486 · Class 2	Gleamer	FR	Radiology	9 Sep 2026
Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3) K262488 · Class 2	Guangzhou Red Pine Medical Instrument Co., Ltd.	CN	Gastroenterology, Urology	9 Sep 2026
Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim K262542 · Class 1	Top Glove Sdn. Bhd.	MY	General Hospital	9 Sep 2026
ColActive Plus K260652 · Class U	Covalon Technologies, Ltd.	CA	Unknown	9 Sep 2026
SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01) K260997 · Class 2	Endoclot Plus Co., Ltd.	CN	Gastroenterology, Urology	9 Sep 2026
PurGuard360(QF10) K261470 · Class 2	E.A.M Benelux B.V	NL	Gastroenterology, Urology	9 Sep 2026
ReVISION 2 K251417 · Class 2	Argus Cognitive, Inc.	US	Radiology	9 Sep 2026
EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H K260227 · Class 2	DRTECH Corporation	KR	Radiology	8 Sep 2026
Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30) K254294 · Class 2	Zhejiang Geyi Medical Instrument Co., Ltd.	CN	Obstetrics/Gynecology	8 Sep 2026
da Vinci Surgical System, Model IS5000 K261823 · Class 2	Intuitive Surgical, Inc.	US	Gastroenterology, Urology	8 Sep 2026
MODI System K260062 · Class 2	DreaMed Diabetes, Ltd.	IL	Clinical Chemistry	8 Sep 2026
N22 Offset Humeral Head K262173 · Class 2	Shoulder Innovations, Inc.	US	Orthopedic	8 Sep 2026
Emboliner Embolic Protection System (EPC-03) K261715 · Class 2	Emboline, Inc.	US	Cardiovascular	8 Sep 2026
LANDMARK Total Knee System K261462 · Class 2	Smith & Nephew, Inc.	US	Orthopedic	8 Sep 2026
Reusable SmartPeg K261987 · Class 1	Osstell AB	SE	Dental	8 Sep 2026
Power Wheelchair (OS-R-M01I) K260053 · Class 2	Beijing OrionStar Technology Co., Ltd.	CN	Physical Medicine	8 Sep 2026
b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions K262341 · Class 2	B-One Ortho, Corp.	US	Orthopedic	8 Sep 2026
Dental Barriers and Sleeves (AB0006) K261956 · Class 2	ANI Co., Ltd.	KR	General, Plastic Surgery	8 Sep 2026
Electric wheelchair (HC819N, HC830N, HC831N) K260229 · Class 2	Yongkang Hengyi Vehicle Co., Ltd.	CN	Physical Medicine	8 Sep 2026
LiteSet Trays K253988 · Class 2	Nobel Biocare AB	SE	General Hospital	8 Sep 2026
Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid K260312 · Class 1	Gmp Medicare Sdn. Bhd.	MY	General Hospital	8 Sep 2026
Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.) K261131 · Class 2	Shenzhen Osto Medical Technology Co.,Ltd	CN	Neurology	6 Sep 2026
KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) K260396 · Class 2	Fidelity BioPharma Co.	US	Neurology	6 Sep 2026
LipoSurg ARTIST K254135 · Class 2	NOUVAG AG	CH	General, Plastic Surgery	5 Sep 2026
FreezeSpray TA K261684 · Class U	Cryosurgery, Inc.	US	Unknown	5 Sep 2026
NeoPEX Pre-Mixed Obturation Paste K253909 · Class 2	NuSmile, Ltd.	US	Dental	4 Sep 2026
TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221) K260756 · Class 2	Sentinel Medical Technologies,	US	Gastroenterology, Urology	4 Sep 2026
70 NeuGlide Catheter K262277 · Class 2	Piraeus Medical, Inc.	US	Cardiovascular	4 Sep 2026
Peerbridge COR MDx (Cor MDx) K253529 · Class 2	Peerbridge Health, Inc.	US	Cardiovascular	4 Sep 2026
KHEIRON® Spinal Fixation System, including patient specific K-ROD K262828 · Class 2	S.M.A.I.O	FR	Orthopedic	4 Sep 2026
Digital Indeflator INFLANTE K260035 · Class 2	UAB Telemedicina	LT	Cardiovascular	4 Sep 2026
IMMULITE 2000 3gAllergy Specific IgE Vantage; IMMULITE 2000 Systems Peanut Allergen (F13) K260331 · Class 2	Siemens Healthcare Diagnostics Products, Ltd.	GB	Immunology	4 Sep 2026
ATTUNE Revision Knee System K262130 · Class 2	Depuy Orthopaedics, Inc.	US	Orthopedic	4 Sep 2026
ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Automated EM Tracking (187BL4060EM);ApexCut Blade with Automated EM Tracking (187BL2975EM);ApexCut Blade with Automated EM Tracking (187BL3590EM);ApexCut Blade with Automated EM Tracking (187BL4000LEM) K262235 · Class 2	Medtronic Xomed, Inc.	US	Neurology	4 Sep 2026
FCT iStream Phase 2 K253836 · Class 2	Fujifilm Corporation	JP	Radiology	4 Sep 2026
3D-RD-S K262060 · Class 2	Radiopharmaceutical Imaging & Dosimetry, LLC	US	Radiology	4 Sep 2026
Surgical and Prosthetic Trays K261935 · Class 2	Dentsply Sirona, Inc.	US	General Hospital	4 Sep 2026
Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA K254264 · Class 2	Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)	US	Microbiology	4 Sep 2026
Gastric Alimetry K262292 · Class 2	Alimetry , Ltd.	NZ	Gastroenterology, Urology	4 Sep 2026
Sofia Influenza A+B FIA; Sofia RSV FIA; Sofia Strep A+ FIA K254262 · Class 2	Ortho Clinical Diagnostics Inc. (QuidelOrtho)	US	Microbiology	4 Sep 2026
ActivaScrew Cannulated COM K261057 · Class 2	Bioretec, Ltd.	FI	Orthopedic	4 Sep 2026
NextMR Spine K260525 · Class 2	MRI2CT, Inc.	US	Radiology	4 Sep 2026
Tenax® Laser Resistant Endotracheal Tube K251794 · Class 2	Bryan Medical, Inc.	US	Anesthesiology	3 Sep 2026
Mayumi Thrombectomy System K254035 · Class 2	MicroVention, Inc., d/b/a Terumo Neuro	US	Cardiovascular	3 Sep 2026
CROSSLEAD Standard 035 and CROSSLEAD Stiff 035 K261281 · Class 2	Filmecc Co., Ltd.	JP	Cardiovascular	3 Sep 2026
Tempo Plating System; Ultra Compression Screw System K261647 · Class 2	Pace Surgical	US	Orthopedic	3 Sep 2026
Happy Health Blood Pressure Monitor K254000 · Class 2	Happy Health, Inc.	US	Cardiovascular	3 Sep 2026
NeuroBlate System K262315 · Class 2	Monteris Medical	US	General, Plastic Surgery	3 Sep 2026
Mcare System (MW-20) K253673 · Class 2	Marani Health, Inc.	US	Obstetrics/Gynecology	3 Sep 2026
Profisil Free K262243 · Class 2	Kettenbach GmbH & Co. KG	DE	Dental	3 Sep 2026
Triton 1 System K260503 · Class 2	Neptune Medical, Inc.	US	Gastroenterology, Urology	3 Sep 2026
Permatage XT Settable Nonabsorbable Hemostatic Bone Putty (OS-PER-1001XT) K262769 · Class U	Orthocon, Inc.	US	Unknown	3 Sep 2026
HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based lubricant (WL-OR); HARU STEAMY water based lubricant (WL-ST) K253989 · Class 2	Maxigen Biotech, Inc.	TW	Obstetrics/Gynecology	3 Sep 2026
STEMI AI ECG Model DEN250044	Powerful Medical, Inc.	US	Unknown	3 Sep 2026
Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62) K261622 · Class 2	Philips Consumer Lifestyle B.V.	NL	Obstetrics/Gynecology	3 Sep 2026
Helo Max Thrombectomy System (HEL2090) K261800 · Class 2	Endovascular Engineering	US	Cardiovascular	3 Sep 2026
Rezum System K262460 · Class 2	Boston Scientific	US	Gastroenterology, Urology	3 Sep 2026
ArthroTAK Tendon Anchor Kit K262809 · Class 2	ArthroTAK, LLC	US	Orthopedic	2 Sep 2026
I-View® K254090 · Class 2	Hologic, Inc.	US	Radiology	2 Sep 2026
Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K261749	Cardinalhealth	US	Unknown	2 Sep 2026
Ruby Intravascular Catheter K260432 · Class 2	Venocare, Inc.	US	General Hospital	2 Sep 2026
Ellian Enigma RF Device K262364 · Class 2	Ellian Corp	US	General, Plastic Surgery	2 Sep 2026
Momentum Acetabular Cup System K253948 · Class 2	United Orthopedic Corporation	TW	Orthopedic	2 Sep 2026
3.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U); 6.0mm Large ProVu Video Bronchoscope (090-02-0060U); ProVu Video Bronchoscope 8 display (040-07-0082U) K254026 · Class 2	Flexicare Medical Limited.	GB	Ear, Nose, Throat	2 Sep 2026
HYALOMATRIX K261311 · Class U	Anika Therapeutics, Inc.	US	Unknown	2 Sep 2026
Vivid Explorer/Vivid Advanced/Vivid Focus K261313 · Class 2	GE Medical Systems Ultrasound and Primary Care Diagnostics	US	Radiology	2 Sep 2026
Aevumed SUPERCYNCH Button System K253065 · Class 2	Aevumed, Inc.	US	Orthopedic	2 Sep 2026
Trexo Theo K254198 · Class 2	Trexo Robotics, Inc.	CA	Physical Medicine	2 Sep 2026
Pivot Insulin Delivery System K262153 · Class 2	Modular Medical, Inc.	US	General Hospital	2 Sep 2026
Maverix Cryo Biopsy Pro (MCB Pro) (MCBP-1000); Maverix Cryo Cartridge (CC-1000) K262420 · Class 2	Serpex Medical	US	General, Plastic Surgery	2 Sep 2026
1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) K261589 · Class 2	Zhengzhou PZ Laser Slim Technology Co., Ltd.	CN	General, Plastic Surgery	2 Sep 2026
Arthrex DynaNite Staples K262451 · Class 2	Arthrex, Inc.	US	Orthopedic	1 Sep 2026
Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM 1.8M; TruSignal SpO2 MM 3.0M K260656 · Class 2	GE Healthcare Finland Oy	FI	Cardiovascular	1 Sep 2026
RadiForce MX247W K262783 · Class 2	Eizo Corporation	JP	Radiology	1 Sep 2026
SK Knee System K253961 · Class 2	Just Medical Devices (Tianjin) Co., Ltd.	CN	Orthopedic	1 Sep 2026
CO2 Laser System (MBT- CO2 Laser) K262269 · Class 2	Beijing Mega Beauty Technology Co., Ltd.	CN	General, Plastic Surgery	1 Sep 2026
MAGNETOM Free.Max; MAGNETOM Free.Star K260758 · Class 2	Siemens Shenzhen Magnetic Resonance , Ltd.	CN	Radiology	1 Sep 2026
AMI Plasma Cartridge, AMI K260613 · Class 1	Sequitur Health Corp.	US	Clinical Chemistry	1 Sep 2026
UNIDRIVE Select System K260884 · Class 2	Karl Storz SE & CO. KG	DE	Gastroenterology, Urology	1 Sep 2026
Wearable breast pump (Model: XN/MD-2249BS, ZFHF) K262774 · Class 2	Guangdong Horigen Mother & Baby Products Co., Ltd.	CN	Obstetrics/Gynecology	1 Sep 2026
PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) K261811 · Class 2	PRIMED Medical Products, Inc.	CA	General, Plastic Surgery	1 Sep 2026
Lipipor NLF1A Infusion Filter, Lipipor NLF2A & NLF2NTA Infusion Filters, Lipipor TNA2A Infusion Filter K261403 · Class 2	Global Life Sciences Solutions USA, LLC	US	General Hospital	31 Aug 2026
Nova HD+ K262788 · Class 2	Aura Wellness, LLC	US	Physical Medicine	31 Aug 2026
MULTIX Impact; MULTIX Impact C K260488 · Class 2	Siemens Medical Solutions USA, Inc.	US	Radiology	31 Aug 2026
ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0 K262747 · Class 2	Abbott Diagnostics Scarborough, Inc.	US	Microbiology	31 Aug 2026
SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003) K260387 · Class 2	Hironic Co., Ltd.	CN	Neurology	31 Aug 2026
Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907) K260767 · Class 2	Kam Yuen Plastic Products , Ltd.	CN	General, Plastic Surgery	31 Aug 2026
Automatic Digital Blood Pressure monitor (LD-526) K262658 · Class 2	Honsun (Nantong) Co., Ltd.	CN	Cardiovascular	31 Aug 2026
Aerloom K254217 · Class 2	Evolym, LLC	US	Cardiovascular	31 Aug 2026
Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) K261695 · Class 2	Guilin Kevin Peter Technology Co., Ltd.	CN	Dental	31 Aug 2026
EZFluence (RADEZ V2) K261718 · Class 2	Radformation, Inc.	US	Radiology	31 Aug 2026
cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) K260045 · Class 2	Roche Molecular Systems, Inc.	US	Microbiology	28 Aug 2026
Carescape Canvas 1000; Carescape Canvas Smart Display K260343 · Class 2	GE Healthcare Finland Oy	FI	Cardiovascular	28 Aug 2026
Automatic Core Biopsy Instrument K260517 · Class 2	Zhejiang Curaway Medical Technology Co., Ltd.	CN	Gastroenterology, Urology	28 Aug 2026
Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK) K254261 · Class 2	CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.	CN	Obstetrics/Gynecology	28 Aug 2026
Tigertriever 13 Ultra Revascularization Device K260617 · Class 2	Rapid Medical Ltd.	IL	Cardiovascular	28 Aug 2026
Rayvolve AZchest K261378 · Class 2	AZmed	FR	Radiology	28 Aug 2026
Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) K261582 · Class 2	Zhengzhou PZ Laser Slim Technology Co., Ltd.	CN	General, Plastic Surgery	28 Aug 2026
Primal K-Wire (P99-193-1410) K262722 · Class 2	Paragon 28, Inc.	US	Orthopedic	28 Aug 2026
Fule Vertebroplasty Balloon Catheter K260203 · Class 2	Beijing Fule Science & Technology Development Co., Ltd.	CN	Orthopedic	28 Aug 2026
X-Guide Surgical Navigation System K253954 · Class 2	X-Nav Technologies, LLC	US	Dental	28 Aug 2026

Showing the 150 most recent of 684 decisions. Search the full list in the FDA 510(k) database.

How this page is built

Every row on this page is copied from the FDA's public 510(k) records through openFDA. Contact names and street addresses in those records are deliberately not shown. openFDA's own notice applies: do not rely on openFDA to make decisions regarding medical care; results should be assumed unvalidated.

openFDA 510(k) API (U.S. Food and Drug Administration) ↗ K number, device name, applicant, city and country, decision date and type, device class and medical specialty for every row on this page

A daily job queries openFDA for all 510(k) decisions where the applicant's country is Ireland, and all decisions in the last 90 days, then tabulates the registry fields directly. There is no AI drafting and no editorial pass. The date above is the time of that sync. Each K number links to its official FDA record. Our general approach is set out in our editorial standards. The openFDA data on this page was last retrieved on 26 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.

FDA medical device clearances

Irish MedTech: FDA clearances to Irish-based applicants

Irish applicants by clearances

Irish clearances by town

All FDA 510(k) clearances, last 90 days

How this page is built