FDA applicant
Orifice Medical AB
FDA records 2 decisions for Orifice Medical AB (Ystad, SE) in 1999: 2 510(k) clearances. All are in product code HHT (Spatula, Cervical, Cytological). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Orifice Medical AB’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Orifice Medical AB since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Orifice Medical AB’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report