Data / Medical devices / Isle of Man
Medical device makers in Isle of Man: 2 FDA-registered establishments
2 establishments in Isle of Man are registered with the FDA to make medical devices for the US market, listing 3 device types. 2 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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- Isle of ManCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 1 |
| Analyzer, Body Composition | MNW | 1 |
| Cream, Nasal, Topical, Mechanical Allergen Particle Barrier | NUP | 1 |
Makers in Isle of Man
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Bodystat Ltd | Isle of Man, Isle of Man | 2 | 4 | 0 | 0 | api.fda.gov |
| Nasaleze Group | Douglas, Isle of Man | 1 | 3 | 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.