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Plastalume
BROWNMED, INC. · Model 12123 · UDI-DI 00082161121237
10
510(k) clearances
47
Adverse events
1
Recalls
427
Facilities
Description
Classic Forearm Splint
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-18 | North Coast Medical Inc | The thumb strap of the wrist and thumb orthosis may contain latex that is not declared in the product labeling. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.