FDA applicant
A.M.I. Agency For Medical Innovations GmbH
FDA records 1 decision for A.M.I. Agency For Medical Innovations GmbH (Feldkirch, AT) in 2025: 1 510(k) clearance. All are in product code HET (Laparoscope, Gynecologic (And Accessories)). Its devices cite 1 predicate, 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 A.M.I. Agency For Medical Innovations GmbH’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
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