FDA applicant
Bioseal
FDA records 10 decisions for Bioseal (Brea, CA) from 1988 to 1989: 10 510(k) clearances. Most are in product codes GDY (Gauze/Sponge, Internal, X-Ray Detectable) and EFQ (Gauze/Sponge, Internal). 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bioseal’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Bioseal since 2007.
Recalls per year
4in 2025
2007high 4 (2025) · low 0 (2007)2026
Class I Class II/III not classified
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