Brainlab AG - FDA 510(k) Cleared Devices
Recent clearances: Viewer (5.4), Spine & Trauma Navigation Instruments, Vascular Navigation PAD 2.0
135
Total
135
Cleared
0
Denied
FDA 510(k) Regulatory Record - Brainlab AG Neurology ✕
59 devices
Cleared
Jan 28, 2025
Alignment System Cranial, with Alignment Software Cranial with LITT
Neurology
60d
Cleared
Sep 09, 2023
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software...
Neurology
260d
Cleared
Jul 21, 2023
Cranial Navigation, Navigation Software Cranial, Navigation Software...
Neurology
269d
Cleared
Apr 19, 2023
Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements...
Neurology
145d
Cleared
Sep 08, 2022
Cranial EM System
Neurology
262d
Cleared
Apr 19, 2022
Brainlab Elements Guide XT, Guide 3.0
Neurology
124d
Cleared
Nov 12, 2021
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial,...
Neurology
224d
Cleared
Nov 03, 2021
Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
Neurology
168d
Cleared
Jan 29, 2021
Disposable Pre-calibrated Suction
Neurology
217d
Cleared
Oct 08, 2020
Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation...
Neurology
377d
Cleared
Sep 06, 2019
Microscope Navigation
Neurology
211d
Cleared
Mar 01, 2018
Microscope Navigation Software
Neurology
164d
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