Medical device manufacturers in Ireland and the U.S. market
65 manufacturers registered in Ireland with at least 5 devices declared in the European database. Of these, 35 were not found in the U.S. FDA establishment register, 27 were matched, and 3 have a similar name that needs checking.
Against the Canadian register, 41 of them were not found, 22 hold a Health Canada licence, and 2 need checking.
| Manufacturer | Devices | FDA | Health Canada |
|---|---|---|---|
| DePuy Ireland UC | 7 807 | Registered with FDA | Licensed in Canada |
| Teleflex Medical | 1 176 | Registered with FDA | Licensed in Canada |
| Trulife | 1 061 | Registered with FDA | Not found in the Canadian register |
| Cardio Surgical Ltd. | 906 | Not found in the FDA register | Not found in the Canadian register |
| OrthoXel DAC | 786 | Similar name found — unverified | Not found in the Canadian register |
| Allard Support UK Ltd | 419 | Not found in the FDA register | Not found in the Canadian register |
| LM Global Design Limited | 363 | Registered with FDA | Not found in the Canadian register |
| ClearStream Technologies Ltd | 226 | Registered with FDA | Licensed in Canada |
| Haleon Medical Devices | 221 | Not found in the FDA register | Not found in the Canadian register |
| Fleming Medical | 214 | Not found in the FDA register | Not found in the Canadian register |
| Techno-path Manufacturing Ltd. | 207 | Registered with FDA | Licensed in Canada |
| Sahajanand Medical Technologies Ireland Limited | 176 | Not found in the FDA register | Similar name found — unverified |
| Natus Manufacturing Limited | 171 | Registered with FDA | Licensed in Canada |
| OACP IE LTD | 162 | Not found in the FDA register | Not found in the Canadian register |
| Cordis Cashel | 132 | Not found in the FDA register | Licensed in Canada |
| AMO Ireland | 116 | Not found in the FDA register | Not found in the Canadian register |
| Fannin Ltd. | 115 | Not found in the FDA register | Not found in the Canadian register |
| Beckman Coulter Ireland Inc. | 109 | Registered with FDA | Licensed in Canada |
| DMC Medical Ltd | 101 | Registered with FDA | Licensed in Canada |
| CF Pharma Ireland Ltd | 99 | Not found in the FDA register | Not found in the Canadian register |
| Isol8 Healthcare Ltd | 84 | Not found in the FDA register | Not found in the Canadian register |
| Stafford-Miller (Ireland) Limited | 80 | Not found in the FDA register | Not found in the Canadian register |
| Creagh Medical Ltd | 72 | Registered with FDA | Licensed in Canada |
| Tcoag ireland ltd | 64 | Registered with FDA | Licensed in Canada |
| Merck Millipore Ltd | 61 | Registered with FDA | Licensed in Canada |
| Serosep Limited | 49 | Not found in the FDA register | Not found in the Canadian register |
| 151 Products (Ireland) | 48 | Not found in the FDA register | Not found in the Canadian register |
| Integra LifeSciences (Ireland) Limited | 39 | Registered with FDA | Licensed in Canada |
| EVB Sport Shorts Ltd | 35 | Not found in the FDA register | Not found in the Canadian register |
| Ostoform Limited | 35 | Registered with FDA | Not found in the Canadian register |
| Aerogen Ltd | 33 | Registered with FDA | Licensed in Canada |
| VascoCare Medical Limited | 31 | Not found in the FDA register | Not found in the Canadian register |
| HidraMed Solutions Limited | 30 | Registered with FDA | Not found in the Canadian register |
| GS Medical | 27 | Registered with FDA | Not found in the Canadian register |
| Lake Region Medical (Galway) | 25 | Similar name found — unverified | Similar name found — unverified |
| AOTI Limited | 22 | Registered with FDA | Licensed in Canada |
| Verity Medical Ltd. | 21 | Not found in the FDA register | Licensed in Canada |
| Avery Dennison Medical | 19 | Registered with FDA | Not found in the Canadian register |
| Hader Solutions and Distribution LTD | 19 | Similar name found — unverified | Not found in the Canadian register |
| Rottapharm Ltd | 18 | Not found in the FDA register | Licensed in Canada |
| Jahan Co. Unlimited Company | 17 | Not found in the FDA register | Not found in the Canadian register |
| Meditec Medical Limited | 16 | Not found in the FDA register | Not found in the Canadian register |
| Unique Perspectives Limited | 14 | Not found in the FDA register | Not found in the Canadian register |
| CMC HYGEA LTD | 13 | Not found in the FDA register | Not found in the Canadian register |
| Ovelle Ltd | 13 | Not found in the FDA register | Not found in the Canadian register |
| GlaxoSmithKline Trading Services Limited | 12 | Not found in the FDA register | Not found in the Canadian register |
| Sedana Medical Limited | 12 | Not found in the FDA register | Licensed in Canada |
| LABORATOIRE PURESSENTIEL IRELAND LIMITED | 10 | Not found in the FDA register | Not found in the Canadian register |
| DentalOrganiser Ltd | 9 | Not found in the FDA register | Not found in the Canadian register |
| LC Seating LTD | 9 | Not found in the FDA register | Not found in the Canadian register |
| PrivaPath Diagnostics Limited | 9 | Registered with FDA | Not found in the Canadian register |
| Vitalograph (Ireland) Limited | 9 | Registered with FDA | Licensed in Canada |
| phenox Ltd | 8 | Registered with FDA | Licensed in Canada |
| Incereb Ltd | 7 | Registered with FDA | Not found in the Canadian register |
| Stylite Designs | 7 | Not found in the FDA register | Not found in the Canadian register |
| Suirsafe Technologies Ltd. | 7 | Not found in the FDA register | Not found in the Canadian register |
| Biotech Europe Meditech Inc Limited | 6 | Registered with FDA | Not found in the Canadian register |
| Cook Ireland Limited | 6 | Registered with FDA | Licensed in Canada |
| Davion Healthcare PLC | 6 | Not found in the FDA register | Not found in the Canadian register |
| Neuromod Devices Limited | 6 | Registered with FDA | Licensed in Canada |
| Abbott Ireland, Diagnostics Division | 5 | Registered with FDA | Licensed in Canada |
| Mirai Medical Limited | 5 | Not found in the FDA register | Not found in the Canadian register |
| PMD Device Solutions Ltd | 5 | Not found in the FDA register | Not found in the Canadian register |
| Sanitas Healthcare Limited | 5 | Not found in the FDA register | Not found in the Canadian register |
| Scope Ophthalmics Limited | 5 | Not found in the FDA register | Not found in the Canadian register |
Other countries
- Germany (1071)
- Italy (805)
- France (491)
- United Kingdom (395)
- Poland (279)
- Spain (256)
- Netherlands (214)
- Switzerland (194)
- Sweden (163)
- Finland (131)
- Denmark (113)
- Belgium (106)
- Czechia (97)
- Austria (79)
- Portugal (58)