Brainlab AG - FDA 510(k) Cleared Devices
135
Total
135
Cleared
0
Denied
135 devices
Cleared
Apr 19, 2022
Brainlab Elements Guide XT, Guide 3.0
Neurology
124d
Cleared
Apr 13, 2022
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument...
Orthopedic
268d
Cleared
Dec 16, 2021
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements...
Radiology
134d
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
Jul 22, 2021
ExacTrac Dynamic
Radiology
29d
Cleared
Apr 09, 2021
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS,...
Radiology
113d
Cleared
Mar 18, 2021
Automatic Registration
Orthopedic
91d
Cleared
Jan 29, 2021
Disposable Pre-calibrated Suction
Neurology
217d
Cleared
Dec 23, 2020
CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal,...
Orthopedic
128d
Cleared
Nov 12, 2020
ExacTrac Dynamic
Radiology
17d
Cleared
Oct 08, 2020
Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation...
Neurology
377d
Cleared
Aug 19, 2020
Cranial 4Pi Immobilization
Radiology
26d
Cleared
Jul 13, 2020
ExacTrac Dynamic
Radiology
61d
Cleared
Jun 02, 2020
HIP7
Orthopedic
186d
Cleared
Jan 23, 2020
Elements Viewer
Radiology
281d
Cleared
Sep 06, 2019
Microscope Navigation
Neurology
211d
Cleared
Aug 29, 2019
Spine & Trauma Navigation
Orthopedic
246d
Cleared
Jun 11, 2019
Spine & Trauma Navigation
Orthopedic
29d
Cleared
Apr 25, 2019
Brainlab Elements Image Fusion Angio
Radiology
106d
Cleared
Apr 12, 2019
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive...
Radiology
28d
Cleared
Mar 01, 2018
Microscope Navigation Software
Neurology
164d
Cleared
Sep 26, 2017
Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine...
Radiology
190d
Cleared
Aug 24, 2017
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive...
Radiology
164d
Cleared
Apr 13, 2016
DICOM Viewer
Radiology
114d
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