FDA applicant
Comerge AG
FDA records 2 decisions for Comerge AG (Zurich, CH) from 2024 to 2025: 2 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and NDC (Calculator, Drug Dose). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Comerge AG’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2024high 1 (2024)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2024.
Planning a device like Comerge AG’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