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Guardian Splint
BM KOREA CO., LTD · Model GGP-L · UDI-DI 08809818038210
10
510(k) clearances
47
Adverse events
1
Recalls
427
Facilities
Description
This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas.
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.