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Data / Medical devices / Medical Device Data System / United Kingdom

FDA-registered makers of Medical Device Data System in the United Kingdom: 10 establishments

10 establishments in the United Kingdom are registered with the FDA to make Medical Device Data System (product code OUG). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Medical Device Data System
Product code
OUG
Country
United Kingdom

Makers of Medical Device Data System in the United Kingdom

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Heartsine Technologies, LtdBELFAST Northern Ireland, United KingdomManufacturer0000api.fda.gov
Huma Therapeutics LimitedLondon England, United KingdomManufacturer0000api.fda.gov
Hopper Healthcare LtdLondon, United KingdomComplaint file establishment, Manufacturer0000api.fda.gov
Mirada Medical LimitedOxford (UK) Oxfordshire, United KingdomManufacturer0000api.fda.gov
Plexus Corp.Bathgate West Lothian, United KingdomContract manufacturer0000api.fda.gov
Spectrum Medical LtdGLOUCESTER Gloucestershire, United KingdomManufacturer0000api.fda.gov
The Magstim Company Ltd.Carmarthenshire Wales, United KingdomManufacturer0000api.fda.gov
Vision RT LimitedLONDON London, City of, United KingdomComplaint file establishment, Specification developer0000api.fda.gov
Vision RT LtdBasingstoke Hampshire, United KingdomManufacturer0000api.fda.gov
Wanda Connected Health Systems LtdRoyston, Herts Cambridgeshire, United KingdomManufacturer0000api.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.