Gleamer is one of 274 FDA 510(k) medical device manufacturers from France in the dataset, ranked by real submission volume.
Gleamer - FDA 510(k) Cleared Devices
Recent clearances: ChestView US (1.1), BoneView, BoneView
3
Total
3
Cleared
0
Denied
Gleamer has 3 FDA 510(k) cleared medical devices. Based in Saint Mand?, FR.
Latest FDA clearance: Sep 2026. Active since 2022. Primary specialty: Radiology.
Browse the FDA 510(k) cleared devices submitted by Gleamer Filter by specialty or product code using the sidebar.
1 submission has an FDA-authorized Predetermined Change Control Plan (PCCP), indicating AI or software-based device development.
FDA 510(k) Regulatory Record - Gleamer
3 devices