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Instrumentarium
Société Chirurgicale Instrumentarium Inc · Model s.50.775 · UDI-DI 00810055472253
10
510(k) clearances
61
Adverse events (1 deaths)
2
Recalls
56
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-04-28 | Acclarent, Inc. | Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date. |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
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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.