Brainlab AG - FDA 510(k) Cleared Devices
135
Total
135
Cleared
0
Denied
Brainlab AG has 135 FDA 510(k) cleared medical devices. Based in Heimstetten, DE.
Latest FDA clearance: Oct 2025. Active since 1996. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Brainlab AG Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Brainlab AG
135 devices
Cleared
Oct 16, 2025
Viewer (5.4)
Radiology
70d
Cleared
Sep 12, 2025
Spine & Trauma Navigation Instruments
Orthopedic
29d
Cleared
Jul 22, 2025
Vascular Navigation PAD 2.0
Radiology
259d
Cleared
Jun 23, 2025
Cranial 4Pi Immobilization
Radiology
266d
Cleared
Jun 17, 2025
RT Elements (4.5)
Radiology
123d
Cleared
Jun 13, 2025
Brainlab Elements (7.0)
Radiology
200d
Cleared
May 16, 2025
Mixed Reality Spine Navigation
Orthopedic
261d
Cleared
Jan 28, 2025
Alignment System Cranial, with Alignment Software Cranial with LITT
Neurology
60d
Cleared
Jul 24, 2024
ExacTrac Dynamic (2.0)
Radiology
161d
Cleared
May 23, 2024
Drill Guide
Orthopedic
70d
Cleared
May 21, 2024
Viewer (5.4)
Radiology
256d
Cleared
Mar 20, 2024
Automatic Registration
Orthopedic
90d
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