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Embozene Microspheres (Opaque)
CELONOVA BIOSCIENCES, INC. · Model 19010-S0 · UDI-DI 00879397003365
8
510(k) clearances
477
Adverse events (18 deaths)
1
Recalls
18
Facilities
Description
Microspheres for Embolization
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-08-17 | Boston Scientific Corporation | Compromised sterility: Boston Scientific is initiating a Recall Removal for twenty (20) UPN codes and 638 associated lots/batches of its Contour SE Microspheres product. All affe |
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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.