# Bioseal

- Location (FDA's records): Brea, CA
- FDA decisions: 10 (1988–1989): 10 510(k) clearances
- Product codes: GDY (3), EFQ (3), ECI (1), CBH (1), NAD (1), LRO (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K893814: Surgical Instrument Kit, Disposable (Aug 10, 1989)
- K882695: Rubber Band, Sterile (Oct 13, 1988)
- K882696: Dermicel, Montgomery Strap (Aug 26, 1988)
- K882694: Fixation Device, Trach Tube (Aug 15, 1988)
- K882708: Gauze Sponge, X-Ray Detectable (Aug 3, 1988)
- K882710: Intestinal Sponges (Aug 3, 1988)
- K882712: Stick Sponge (Aug 3, 1988)
- K882709: Tonsil Sponge, X-Ray Detectable, W/String (Aug 3, 1988)

Source page: https://510kreport.com/company/bioseal