Data / Medical devices / Introducer, Catheter / Ireland
FDA-registered makers of Introducer, Catheter in Ireland: 9 establishments
9 establishments in Ireland are registered with the FDA to make Introducer, Catheter (product code DYB). 5 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Introducer, Catheter
- Product code
- DYB
- Country
- Ireland
Makers of Introducer, Catheter in Ireland
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 2 | March 20, 2025 | 0 | 0 | 0 | api.fda.gov |
| Clearstream Technologies Ltd. | Wexford, Ireland | Manufacturer | 2 | September 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Creagh Medical Ltd. | Co. Galway Galway(County), Ireland | Manufacturer | 1 | April 18, 2019 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences Ireland Limited | Limerick Munster, Ireland | Manufacturer | 1 | March 9, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Ireland | GALWAY Galway(County), Ireland | Specification developer | 1 | August 7, 2015 | 0 | 1 | 1 | api.fda.gov |
| Creganna Medical Ireland Limited | BALLYBRIT Galway(County), Ireland | Contract manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| EPIC MedTec OEM Ireland Limited | ANNACOTTY Limerick(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Freudenberg Medical Ireland Limited | Leitrim, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lake Region Medical Limited | NEW ROSS Wexford, Ireland | Contract manufacturer | 0 | 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.