# Orifice Medical AB

- Location (FDA's records): Ystad, SE
- FDA decisions: 2 (1999–1999): 2 510(k) clearances
- Product codes: HHT (2)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Recent decisions
- K991593: Oribrush - Standard - B002 (Jun 29, 1999)
- K991595: Oribrush - with Protective Tip - B001 (Jun 29, 1999)

Source page: https://510kreport.com/company/orifice-medical
