Bioseal Inc.
BIOSEAL · Model 19980/25 · UDI-DI 00630094199801
10
510(k) clearances
251
Adverse events (1 deaths)
2
Recalls
84
Facilities
Description
Buttons 1/4"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-05-16 | Drs Vascular, Inc | XXX |
| 2006-03-24 | Smith & Nephew, Inc. Endoscopy Division | The implant consists of a T1 and T2 anchor which are joined together by a suture. The T2 portion of the implant may not advance into the deployment position preventing deployment o |
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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.