Medical device makers in Ireland: 142 FDA-registered establishments

Name: FDA-registered medical device makers in Ireland
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

142 establishments in Ireland are registered with the FDA to make medical devices for the US market, listing 710 device types. 86 have a 510(k) clearance or PMA approval on file and 23 have a recall event. FDA data exported November 2, 2026.

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IrelandCountry

Device types made here

Device types with the most registered makers in this country.

Device	Product code	Makers
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	13
Orthopedic Manual Surgical Instrument	LXH	12
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	12
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	12
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	11
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	11
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate	MEH	10
Catheter, Percutaneous	DQY	10
Screw, Fixation, Bone	HWC	9
Electrosurgical, Cutting & Coagulation & Accessories	GEI	9
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer	KRO	9
Introducer, Catheter	DYB	9
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	HSD	8
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	8
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	KWZ	8
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous	MBL	8
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	7
Shoulder Prosthesis, Reverse Configuration	PHX	7
Prosthesis, Hip, Hemi-, Femoral, Metal	KWL	7
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	7
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish	MAY	7
Wrench	HXC	7
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	6
Bit, Drill	HTW	6
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	HRY	6
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive	OIY	6
Cement Obturator	LZN	6
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	LWJ	6
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	KRR	6
Calibrator, Secondary	JIT	6
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	6
Wire, Guide, Catheter	DQX	6
Catheter, Percutaneous, Neurovasculature	QJP	6
Plate, Fixation, Bone	HRS	5
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	KWT	5
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	NPJ	5
Bone Cement	LOD	5
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	5
Catheter, Intravascular, Diagnostic	DQO	5
Catheter, Continuous Flush	KRA	5
Catheter, Thrombus Retriever	NRY	5
Template	HWT	5
Guide, Surgical, Instrument	FZX	5
Catheter, Angioplasty, Peripheral, Transluminal	LIT	5
Wire, Surgical	LRN	5
Catheter, Intravascular Occluding, Temporary	MJN	5
Blade, Saw, General & Plastic Surgery, Surgical	GFA	4
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented	MBF	4
Orthosis, Spinal Pedicle Fixation	MNI	4
Prosthesis, Elbow, Semi-Constrained, Cemented	JDB	4
Thoracolumbosacral Pedicle Screw System	NKB	4
Orthopedic Stereotaxic Instrument	OLO	4
Calibrator, Multi-Analyte Mixture	JIX	4
Device, Vascular, For Promoting Embolization	KRD	4
Stents, Drains And Dilators For The Biliary Ducts	FGE	4
Retractor	GAD	4
Tubes, Gastrointestinal (And Accessories)	KNT	4
Tape, Measuring, Rulers And Calipers	FTY	4
Catheter, Irrigation	GBX	4
Tray, Surgical, Instrument	FSM	4
Screwdriver	HXX	4
Impactor	HWA	4
Peripheral Mechanical Thrombectomy With Aspiration	QEW	4
Dispenser, Cement	KIH	4
Drug-Eluting Peripheral Transluminal Angioplasty Catheter	ONU	4
Stent, Iliac	NIO	4
Stent, Superficial Femoral Artery	NIP	4
Syringe, Piston	FMF	3
Cerclage, Fixation	JDQ	3
Reamer	HTO	3
Cement, Bone, Vertebroplasty	NDN	3
Methyl Methacrylate For Cranioplasty	GXP	3
Rod, Fixation, Intramedullary And Accessories	HSB	3
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	HSN	3
Prosthesis, Elbow, Hemi-, Radial, Polymer	KWI	3
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing	NJL	3
Radioimmunoassay, Estradiol	CHP	3
Multi-Analyte Controls, All Kinds (Assayed)	JJY	3
Radioimmunoassay, Luteinizing Hormone	CEP	3
Radioimmunoassay, Prolactin (Lactogen)	CFT	3
Radioimmunoassay, Total Triiodothyronine	CDP	3
Radioimmunoassay, Free Thyroxine	CEC	3
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	3
Alkaline Picrate, Colorimetry, Creatinine	CGX	3
Radioimmunoassay, Follicle-Stimulating Hormone	CGJ	3
Immunoassay Method, Troponin Subunit	MMI	3
Ferritin, Antigen, Antiserum, Control	DBF	3
Stent, Ureteral	FAD	3
Prosthesis, Hip, Femoral Component, Cemented, Metal	JDG	3
Endoscopic Guidewire, Gastroenterology-Urology	OCY	3
Catheter, Urological	KOD	3
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	3
Radioassay, Vitamin B12	CDD	3
Acid, Folic, Radioimmunoassay	CGN	3
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented	PAO	3
Gauge, Depth	HTJ	3
Awl	HWJ	3
Driver, Prosthesis	HWR	3
Nebulizer (Direct Patient Interface)	CAF	3
Osteotome	HWM	3

Makers in Ireland

Best documented first: most 510(k) clearances and PMA approvals.

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
Boston Scientific Limited	GALWAY Galway(County), Ireland	107	231	22	0	api.fda.gov
Stryker Ireland Osteonics	County Cork, Ireland	43	135	1	0	api.fda.gov
Howmedica International S. De R.L.	LIMERICK Munster, Ireland	39	101	0	0	api.fda.gov
Depuy (ireland)	CO. CORK Munster, Ireland	75	87	3	2	api.fda.gov
Depuy Ireland UC	Co. Cork Munster, Ireland	80	86	2	1	api.fda.gov
Beckman Coulter Ireland Inc	O CALLAGHANS MILLS Clare, Ireland	100	54	0	4	api.fda.gov
Boston Scientific Limited	CORK Munster, Ireland	31	52	1	1	api.fda.gov
Medtronic Ireland	GALWAY Galway(County), Ireland	21	30	14	4	api.fda.gov
Abbott Ireland Diagnostics Division	Longford, Ireland	54	40	0	5	api.fda.gov
Stryker Ireland Ltd. Instruments Division, Innovation Centre	Carrigtwohill Cork(County), Ireland	27	33	0	0	api.fda.gov
Signature Orthopaedics Europe Ltd	Athlone Westmeath, Ireland	31	29	0	1	api.fda.gov
Cook Ireland Ltd	LIMERICK Limerick(County), Ireland	19	22	3	1	api.fda.gov
Tcoag Ireland Limited	BRAY Wicklow, Ireland	14	25	0	0	api.fda.gov
Stryker Neurovascular	Cork Munster, Ireland	10	21	2	0	api.fda.gov
Boston Scientific Limited	CLONMEL Tipperary, Ireland	25	13	9	0	api.fda.gov
Abbott Ireland	Sligo, Ireland	33	15	6	1	api.fda.gov
KCI Manufacturing	Athlone - Co. Westmeath, Ireland	3	21	0	0	api.fda.gov
Vitalograph Ireland Ltd.	Co Clare, Ireland	11	21	0	0	api.fda.gov
Covidien	- Galway(County), Ireland	14	18	1	2	api.fda.gov
Integra Lifesciences (ireland) Limited	SRAGH TULLAMORE Offaly, Ireland	10	15	0	0	api.fda.gov
Mallinckrodt Medical	ATHLONE Westmeath, Ireland	7	15	0	0	api.fda.gov
Stryker Macroom	Co Cork Munster, Ireland	14	15	0	0	api.fda.gov
Natus Manufacturing Limited	GORT, Co. Galway(County), Ireland	27	14	0	2	api.fda.gov
Zimmer Orthopedic Mfg Ltd	Shannon Clare, Ireland	9	13	1	1	api.fda.gov
Merit Medical Ireland, Ltd	Galway Galway(County), Ireland	33	13	0	0	api.fda.gov
Siemens Healthcare Diagnostics Manufacturing Ltd.	SWORDS Dublin(County), Ireland	51	12	0	0	api.fda.gov
Brivant, Ltd.	GALWAY Galway(County), Ireland	2	11	0	0	api.fda.gov
Johnson & Johnson Vision Care Ireland Unlimited Company	. Limerick(County), Ireland	3	9	2	0	api.fda.gov
Perfuze	Dangan Galway(County), Ireland	2	11	0	0	api.fda.gov
Zimmer Orthopedics Manufacturing Limited-Galway	Oranmore Galway(County), Ireland	16	11	0	1	api.fda.gov
Bausch & Lomb Ireland Limited T/A Bausch and Lomb Ireland	WATERFORD Munster, Ireland	3	8	2	0	api.fda.gov
Creagh Medical Ltd.	Co. Galway Galway(County), Ireland	5	10	0	0	api.fda.gov
Hollister ULC	REHINS BALLINA Mayo, Ireland	4	10	0	1	api.fda.gov
Clearstream Technologies Ltd.	Wexford, Ireland	7	8	1	0	api.fda.gov
Abbott Vascular	CLONMEL Tipperary, Ireland	8	3	5	0	api.fda.gov
Trinity Biotech, Plc	BRAY Wicklow, Ireland	12	8	0	0	api.fda.gov
Aerogen Ltd	DANGAN Galway(County), Ireland	3	7	0	1	api.fda.gov
Merck Millipore Ltd.	COUNTY CORK Munster, Ireland	5	7	0	1	api.fda.gov
Phenox Limited	Galway Galway(County), Ireland	6	7	0	0	api.fda.gov
Techno-Path Manufacturing Ltd.	Ballina Tipperary, Ireland	5	7	0	3	api.fda.gov
Aerogen Ltd.	GALWAY Galway(County), Ireland	3	6	0	0	api.fda.gov
Neuravi Limited	Galway Galway(County), Ireland	2	6	0	0	api.fda.gov
Verity Medical Ltd (Ireland)	Tagoat Wexford, Ireland	8	6	0	0	api.fda.gov
Privapath Diagnostics Ltd	Dublin 11 Dublin(County), Ireland	9	5	0	1	api.fda.gov
Teleflex Medical	ATHLONE Westmeath, Ireland	4	5	0	7	api.fda.gov
Abbott Ireland Diabetes Care	Donegal Town, Ireland	2	4	0	0	api.fda.gov
Edwards Lifesciences Ireland Limited	Limerick Munster, Ireland	7	1	3	0	api.fda.gov
Alcon Laboratories Ireland Ltd.	CORK Cork(City), Ireland	4	0	3	1	api.fda.gov
Aoti Ltd.	GALWAY Galway(County), Ireland	2	3	0	0	api.fda.gov
Aerogen Shannon	Co. Clare, Ireland	2	3	0	0	api.fda.gov
Dexcom International Limited	Athenry Galway(County), Ireland	4	3	0	0	api.fda.gov
Lake Region Medical Limited	NEW ROSS Wexford, Ireland	12	3	0	0	api.fda.gov
Neurent Medical Ltd	Galway Galway(County), Ireland	1	3	0	0	api.fda.gov
Orthoxel	Cork Cork(City), Ireland	11	3	0	0	api.fda.gov
Palliare	Galway Galway(County), Ireland	4	3	0	0	api.fda.gov
embecta Penel Limited	Dun Laoghaire Co. Dublin(County), Ireland	1	3	0	0	api.fda.gov
Aventamed Dac	Bishopstown Cork(City), Ireland	1	2	0	0	api.fda.gov
Abbott Ireland, ADC Kilkenny	Kilkenny, Ireland	3	2	0	0	api.fda.gov
Cardinal Health Ireland Manufacturing Limited	TULLAMORE Offaly, Ireland	3	2	0	0	api.fda.gov
DMC Medical Ltd.	SHANNON Clare, Ireland	5	2	0	0	api.fda.gov
Ema Aesthetic Ltd	Dublin Dublin(City), Ireland	4	2	0	0	api.fda.gov
Marvao Medical Devices Ltd.	Galway Galway(County), Ireland	2	2	0	1	api.fda.gov
Proverum Limited	DUBLIN 1 Dublin(County), Ireland	2	1	1	0	api.fda.gov
Proverum Limited	Galway Galway(County), Ireland	2	1	1	0	api.fda.gov
Rockfield Medical Devices Ltd.	Galway Galway(County), Ireland	3	2	0	0	api.fda.gov
Vantive Manufacturing Limited	SWINFORD Mayo, Ireland	2	2	0	0	api.fda.gov
X-Bolt Orthopedics	Santry Dublin(County), Ireland	2	2	0	0	api.fda.gov
Allergan Pharmaceuticals Ireland	WESTPORT Mayo, Ireland	2	1	0	0	api.fda.gov
Cosmo Technologies Ltd.	Dublin 2 Dublin(County), Ireland	1	1	0	0	api.fda.gov
Enterasense Limited	Galway Galway(County), Ireland	1	1	0	0	api.fda.gov
Filtertek, B.V. (an Itw Medical Company)	Newcastle West Limerick(County), Ireland	1	1	0	0	api.fda.gov
Healthbeacon	Dublin Dublin(County), Ireland	2	1	0	0	api.fda.gov
Incereb Ltd	Dublin Dun Laoghaire-Rathdown, Ireland	1	1	0	0	api.fda.gov
Mylan Teoranta	Co. Galway Galway(County), Ireland	2	1	0	0	api.fda.gov
Medical Currents Ltd	Dublin Dublin(County), Ireland	1	1	0	0	api.fda.gov
Neuromod Devices Limited	Dublin Dublin(City), Ireland	1	1	0	0	api.fda.gov
Novaerus Ltd	Blackrock Dublin(County), Ireland	1	1	0	0	api.fda.gov
Randox Teoranta	Dungloe Donegal, Ireland	13	1	0	0	api.fda.gov
Signum Surgical Limited	Galway Galway(City), Ireland	1	1	0	0	api.fda.gov
Store-All Logistics Ltd	Slieverue Kilkenny, Ireland	1	0	1	0	api.fda.gov
Therakos Development Limited	Blanchardstown Dublin(County), Ireland	1	0	1	1	api.fda.gov
Vasorum	Dublin Dublin(County), Ireland	1	0	1	0	api.fda.gov
Veryan Medical Limited	Galway Galway(County), Ireland	1	0	1	0	api.fda.gov
Vetex Medical Limited	Ballinasloe Galway(County), Ireland	2	1	0	0	api.fda.gov
Vantive Manufacturing Limited	CASTLEBAR, COUNTY MAYO Connaught, Ireland	2	1	0	0	api.fda.gov
Waters Technologies Ireland, Ltd.	DRINAGH Wexford, Ireland	7	1	0	0	api.fda.gov
Advant Medical Ltd	BallyBrit Galway(County), Ireland	1	0	0	0	api.fda.gov
Aps Materials Inc. Ireland	Waterford Waterford(County), Ireland	21	0	0	0	api.fda.gov
Arrotek Medical Ltd	Co. Sligo Connaught, Ireland	4	0	0	0	api.fda.gov
AbbVie Ireland NL B.V. Ballytivnan	Sligo, Ireland	3	0	0	0	api.fda.gov
ArcRoyal uc	Kells Meath, Ireland	6	0	0	0	api.fda.gov
Avery Dennison Medical Ltd.	Longford, Ireland	4	0	0	0	api.fda.gov
Beats Medical	Sandyford Dublin(County), Ireland	1	0	0	0	api.fda.gov
Biotech Europe Meditech Inc Ltd	Roscommon, Ireland	1	0	0	0	api.fda.gov
BLUEDROP MEDICAL Ltd	Galway Galway(County), Ireland	1	0	0	0	api.fda.gov
Bluepoint Laboratories	Cork Munster, Ireland	1	0	0	0	api.fda.gov
Caragh Precision	Galway Galway(County), Ireland	24	0	0	0	api.fda.gov
Creganna Medical Ireland Limited	BALLYBRIT Galway(County), Ireland	1	0	0	2	api.fda.gov
Croom Precision Medical	Croom Limerick(County), Ireland	2	0	0	0	api.fda.gov
Danu Medical	Dublin Dublin(County), Ireland	1	0	0	0	api.fda.gov
Digital Rehabilitation Ltd. T/A Vertigenius	Dun Laoghaire Dublin(County), Ireland	1	0	0	0	api.fda.gov
EPIC MedTec OEM Ireland Limited	ANNACOTTY Limerick(County), Ireland	4	0	0	0	api.fda.gov
Edwards Lifesciences LTD	Shannon Clare, Ireland	1	0	0	0	api.fda.gov
Feeltect Ltd	Spiddal Galway(County), Ireland	1	0	0	0	api.fda.gov
FoodMarble Digestive Health Limited	Dublin 8 Dublin(County), Ireland	1	0	0	0	api.fda.gov
Freudenberg Medical Ireland Limited	Leitrim, Ireland	3	0	0	0	api.fda.gov
Gate Dental Services Ltd	Galway Galway(County), Ireland	2	0	0	0	api.fda.gov
HADER Solutions & Distribution Ltd	Swords CO Dublin Dublin(County), Ireland	5	0	0	0	api.fda.gov
Harmac Medical Products	CASTLEREA Roscommon, Ireland	5	0	0	0	api.fda.gov
Hidramed Solutions Limited	Galway Galway(County), Ireland	1	0	0	0	api.fda.gov
Head Diagnostics Ltd	Dublin Dublin(County), Ireland	1	0	0	0	api.fda.gov
Ics Medical Devices Ltd	Galway Galway(City), Ireland	1	0	0	0	api.fda.gov
Idoman Teoranta	Ballinrobe Mayo, Ireland	1	0	0	0	api.fda.gov
Inmo-Tech Ltd.	Sligo, Ireland	2	0	0	0	api.fda.gov
LM Global Design Limited	dublin Dublin(County), Ireland	2	0	0	0	api.fda.gov
Mapaex Health And Personalcare Ireland Private Limited	Newbridge Kildare, Ireland	3	0	0	0	api.fda.gov
Medentech Ltd.	n/a Wexford, Ireland	1	0	0	0	api.fda.gov
Medicare Tags Limited T/A Medytrak	Galway Galway(County), Ireland	1	0	0	0	api.fda.gov
Medisize Ireland Ltd.	LETTERKENNY Donegal, Ireland	6	0	0	0	api.fda.gov
Natus Sensory Ireland Ltd	Gort Galway(County), Ireland	9	0	0	0	api.fda.gov
Nelipak Healthcare Packaging	CLARA, Offaly, Ireland	11	0	0	0	api.fda.gov
Nordson MEDICAL Ireland Limited	Boyle Roscommon, Ireland	1	0	0	0	api.fda.gov
Organic Lens Manufacturing Essidev S.A.	ENINIS Clare, Ireland	1	0	0	0	api.fda.gov
Ostoform Ltd	Mullingar Westmeath, Ireland	2	0	0	0	api.fda.gov
PBC Biomed	Shannon Clare, Ireland	1	0	0	0	api.fda.gov
Proxy Biomedical Ltd.	GALWAY Galway(County), Ireland	3	0	0	0	api.fda.gov
Quasar MED IE (QIE) Limited	Galway Connaught, Ireland	1	0	0	0	api.fda.gov
Rehan Electronics	Carnew Wexford, Ireland	2	0	0	0	api.fda.gov
Safelife Healthcare Ltd.	Galway Galway(City), Ireland	1	0	0	0	api.fda.gov
Schivo	Waterford Waterford(City And County), Ireland	3	0	0	0	api.fda.gov
Smithstown Light Engineering	Shannon Clare, Ireland	12	0	0	0	api.fda.gov
Stryker Ireland Ltd., Instruments Division	CARRIGTWOHILL, CO.CORK Munster, Ireland	18	0	0	0	api.fda.gov
Symmetry Medical Ireland Limited	Midleton, Cork Munster, Ireland	10	0	0	0	api.fda.gov
Sanmina Ireland UC	FERMOY, CORK Munster, Ireland	3	0	0	0	api.fda.gov
Spinal Stabilization Technologies, LTD	Kilkenny, Ireland	1	0	0	0	api.fda.gov
Stafford-Miller Limited	DUNGARVAN Waterford(County), Ireland	3	0	0	0	api.fda.gov
Stryker Anngrove	Cork Munster, Ireland	27	0	0	0	api.fda.gov
Takumi Precision Engineering Ltd	Limerick Limerick(County), Ireland	12	0	0	0	api.fda.gov
Transitions Optical, Ltd.	TUAM Galway(County), Ireland	1	0	0	0	api.fda.gov
Trulife Ltd.	DUBLIN 24 Dublin(County), Ireland	3	0	0	0	api.fda.gov
Tech Group Europe Limited t/a West	Mulhaddart Dublin(County), Ireland	3	0	0	0	api.fda.gov
Utah Medical Products, Ltd.	ATHLONE CO. Leinster, Ireland	6	0	0	0	api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.