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SURGYCO
Surgyco LLC · Model RS000540 · UDI-DI 10850053289702
10
510(k) clearances
115
Adverse events
1
Recalls
161
Facilities
Description
Anesthesia Face Mask Pediatric #2
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. |
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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.