FDA applicant
General Medical Merate S.P.A
FDA records 7 decisions for General Medical Merate S.P.A (Seriate, IT) from 1982 to 2021: 7 510(k) clearances. Most are in product codes JAA (System, X-Ray, Fluoroscopic, Image-Intensified) and OWB (Interventional Fluoroscopic X-Ray System). 8 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided General Medical Merate S.P.A’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
2in 2015
Class I Class II/III not classified
Planning a device like General Medical Merate S.P.A’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