Brainlab SE is one of 467 FDA 510(k) medical device manufacturers from Germany in the dataset, ranked by real submission volume.
Brainlab SE - FDA 510(k) Cleared Devices
Recent clearances: Spine Planning (3.0), ExacTrac Dynamic (2.0.2)
2
Total
2
Cleared
0
Denied
Brainlab SE has 2 FDA 510(k) cleared medical devices. Based in Munich, DE.
Latest FDA clearance: Sep 2026. Active since 2026. Primary specialty: Orthopedic.
Browse the FDA 510(k) cleared devices submitted by Brainlab SE Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Brainlab SE
2 devices