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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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Advanced Medical Solutions LtdWINSFORD Cheshire East, United KingdomManufacturer13October 26, 2023010api.fda.gov
Smith & Nephew Medical LtdHULL East Riding of Yorkshire, United KingdomForeign private label distributor, Manufacturer, Specification developer11August 18, 2023000api.fda.gov
ConvaTec Limited, GDC BuildingDeeside Flintshire, United KingdomSpecification developer7July 20, 2018000api.fda.gov
Convatec LimitedDeeside Flintshire, United KingdomManufacturer5July 20, 2018000api.fda.gov
Medtrade Products Ltd.CHESHIRE Cheshire East, United KingdomManufacturer, Specification developer3October 26, 2012000api.fda.gov
Speciality Fibres and Materials LimitedCoventry, United KingdomComplaint file establishment, Contract manufacturer, Contract sterilizer, Manufacturer3October 21, 2024000api.fda.gov
Brightwake LtdKirkby-in-Ashfield Nottinghamshire, United KingdomContract manufacturer, Manufacturer2July 26, 2011000api.fda.gov
Molnlycke Health CareOldham, United KingdomManufacturer1August 25, 2016000api.fda.gov
Arden Medical Ltd.ALCESTER, WARKS Warwickshire, United KingdomContract manufacturer0000api.fda.gov
BDK Industrial Products LtdIpswich Suffolk, United KingdomContract manufacturer0000api.fda.gov
First Water Ramsbury LtdMarlborough Wiltshire, United KingdomContract manufacturer0000api.fda.gov
Parafix Tapes & Conversions LimitedLancing West Sussex, United KingdomContract manufacturer0000api.fda.gov
Polarseal Tapes And ConversionsSaxmundham Suffolk, United KingdomContract manufacturer0000api.fda.gov
Systagenix Wound Management Manufacturing LimitedNorth Yorkshire, United KingdomContract manufacturer, Contract sterilizer0000api.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.