Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

135 results for "Brainlab AG"
25–48 of 135
Search insights Median review: 141d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Neurology
Cleared Apr 29, 2022
ExacTrac Dynamic
K220338 · IYE
Brainlab AG
Radiology · 81d
Cleared Apr 19, 2022
Brainlab Elements Guide XT, Guide 3.0
K213930 · QQC
Brainlab AG
Neurology · 124d
Cleared Apr 13, 2022
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument...
K212245 · OLO
Brainlab AG
Orthopedic · 268d
Cleared Dec 16, 2021
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements...
K212420 · LLZ
Brainlab AG
Radiology · 134d
Cleared Nov 12, 2021
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial,...
K210989 · HAW
Brainlab AG
Neurology · 224d
Cleared Nov 03, 2021
Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization
K211544 · HAW
Brainlab AG
Neurology · 168d
Cleared Jul 22, 2021
ExacTrac Dynamic
K211939 · IYE
Brainlab AG
Radiology · 29d
Cleared Apr 09, 2021
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS,...
K203681 · MUJ
Brainlab AG
Radiology · 113d
Cleared Mar 18, 2021
Automatic Registration
K203679 · OLO
Brainlab AG
Orthopedic · 91d
Cleared Jan 29, 2021
Disposable Pre-calibrated Suction
K201752 · HAW
Brainlab AG
Neurology · 217d
Cleared Dec 23, 2020
CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal,...
K202320 · OLO
Brainlab AG
Orthopedic · 128d
Cleared Nov 12, 2020
ExacTrac Dynamic
K203173 · IYE
Brainlab AG
Radiology · 17d
Cleared Oct 08, 2020
Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation...
K192703 · HAW
Brainlab AG
Neurology · 377d
Cleared Aug 19, 2020
Cranial 4Pi Immobilization
K202050 · IYE
Brainlab AG
Radiology · 26d
Cleared Jul 13, 2020
ExacTrac Dynamic
K201276 · IYE
Brainlab AG
Radiology · 61d
Cleared Jun 02, 2020
HIP7
K193307 · OLO
Brainlab AG
Orthopedic · 186d
Cleared Jan 23, 2020
Elements Viewer
K191014 · LLZ
Brainlab AG
Radiology · 281d
Cleared Sep 06, 2019
Microscope Navigation
K190250 · HAW
Brainlab AG
Neurology · 211d
Cleared Aug 29, 2019
Spine & Trauma Navigation
K183605 · OLO
Brainlab AG
Orthopedic · 246d
Cleared Jun 11, 2019
Spine & Trauma Navigation
K191285 · OLO
Brainlab AG
Orthopedic · 29d
Cleared Apr 25, 2019
Brainlab Elements Image Fusion Angio
K190042 · LLZ
Brainlab AG
Radiology · 106d
Cleared Apr 12, 2019
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive...
K190664 · MUJ
Brainlab AG
Radiology · 28d
Cleared Mar 01, 2018
Microscope Navigation Software
K172820 · HAW
Brainlab AG
Neurology · 164d
Cleared Sep 26, 2017
Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine...
K170816 · LLZ
Brainlab AG
Radiology · 190d