Leone S.P.A. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Leone S.P.A. - FDA 510(k) Cleared Devices
Recent clearances: Leone Orthodontic Implant TAD (Temporary Anchorage Device)
4
Total
4
Cleared
0
Denied
Leone S.P.A. has 4 FDA 510(k) cleared medical devices. Based in Irvine, US.
Latest FDA clearance: Jun 2025. Active since 2006. Primary specialty: Dental.
Browse the FDA 510(k) cleared devices submitted by Leone S.P.A. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by ProMedic, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Leone S.P.A.
4 devices