Home › NUSMILE, LTD. › Komet BioSeal Tips, 20 count
Komet BioSeal Tips, 20 count
NUSMILE, LTD. · Model KBCS1FT · UDI-DI 00850008515224
10
510(k) clearances
432
Adverse events
1
Recalls
140
Facilities
Description
Flex Tips 20 units
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-02 | Stradis Medical, LLC dba Stradis Healthcare | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in |
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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.