FDA applicant
Agency For Medical Innovations GmbH
FDA records 5 decisions for Agency For Medical Innovations GmbH (Feldkirch, AT) from 2010 to 2021: 5 510(k) clearances. Most are in product codes KOA (Surgical Instruments, G-U, Manual (And…) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 9 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Agency For Medical Innovations, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Agency For Medical Innovations GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2010.
Planning a device like Agency For Medical Innovations GmbH’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