Home › VIVE HEALTH LLC › Arctic Flex
Arctic Flex
VIVE HEALTH LLC · Model SUP2003GRY · UDI-DI 00818323028362
10
510(k) clearances
47
Adverse events
1
Recalls
427
Facilities
Description
Wrist Ice Wrap (Grey)
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. |
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.