Home › BM KOREA CO., LTD › Guardian Splint
Guardian Splint
BM KOREA CO., LTD · Model GLA · UDI-DI 08809818038166
0
510(k) clearances
13
Adverse events
1
Recalls
164
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 |
|---|---|---|
| 2017-11-01 | 3M Company - Health Care Business | Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.