Home › FOREMOUNT ENTERPRISE CO., LTD. › EXIN
EXIN
FOREMOUNT ENTERPRISE CO., LTD. · Model 121821 · UDI-DI 04719871893418
10
510(k) clearances
115
Adverse events
1
Recalls
161
Facilities
Description
Standard cushion mask without valve #1
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-09-12 | Engineered Medical Systems,Inc | The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. |
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.