Data / Medical devices / Dressing, Wound, Drug / United Kingdom
FDA-registered makers of Dressing, Wound, Drug in the United Kingdom: 14 establishments
14 establishments in the United Kingdom are registered with the FDA to make Dressing, Wound, Drug (product code FRO). 8 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Dressing, Wound, Drug
- Product code
- FRO
- Country
- United Kingdom
Makers of Dressing, Wound, Drug in the United Kingdom
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Advanced Medical Solutions Ltd | WINSFORD Cheshire East, United Kingdom | Manufacturer | 13 | October 26, 2023 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew Medical Ltd | HULL East Riding of Yorkshire, United Kingdom | Foreign private label distributor, Manufacturer, Specification developer | 11 | August 18, 2023 | 0 | 0 | 0 | api.fda.gov |
| ConvaTec Limited, GDC Building | Deeside Flintshire, United Kingdom | Specification developer | 7 | July 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Convatec Limited | Deeside Flintshire, United Kingdom | Manufacturer | 5 | July 20, 2018 | 0 | 0 | 0 | api.fda.gov |
| Medtrade Products Ltd. | CHESHIRE Cheshire East, United Kingdom | Manufacturer, Specification developer | 3 | October 26, 2012 | 0 | 0 | 0 | api.fda.gov |
| Speciality Fibres and Materials Limited | Coventry, United Kingdom | Complaint file establishment, Contract manufacturer, Contract sterilizer, Manufacturer | 3 | October 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Brightwake Ltd | Kirkby-in-Ashfield Nottinghamshire, United Kingdom | Contract manufacturer, Manufacturer | 2 | July 26, 2011 | 0 | 0 | 0 | api.fda.gov |
| Molnlycke Health Care | Oldham, United Kingdom | Manufacturer | 1 | August 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Arden Medical Ltd. | ALCESTER, WARKS Warwickshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| BDK Industrial Products Ltd | Ipswich Suffolk, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| First Water Ramsbury Ltd | Marlborough Wiltshire, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Parafix Tapes & Conversions Limited | Lancing West Sussex, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polarseal Tapes And Conversions | Saxmundham Suffolk, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Systagenix Wound Management Manufacturing Limited | North Yorkshire, United Kingdom | Contract manufacturer, Contract sterilizer | 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.