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Brainlab AG

DE

Last updated September 17, 2026

Information

Country
DE
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
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Catalogue (247)

Page 4 of 5
DeviceModel / ReferenceRegistriesClassStatus
Iplan K053127
FDA 510(k)
Class IIActive
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout K252476
FDA 510(k)
Class IIActive
M3 (mirco-Multileaf Collimator K004022
FDA 510(k)
Class IIActive
Vectorvision Uni-Knee K041899
FDA 510(k)
Class IIActive
Iplan Rt Image K080886
FDA 510(k)
Class IIActive
Brainlab Headpins K954789
FDA 510(k)
Class IIActive
Vectorvision Hip 3.0 K040368
FDA 510(k)
Class IIActive
Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial K223864
FDA 510(k)
Class IIActive
Iplan (iplan Cranial, Iplan Stereotaxy, Iplan Ent, Iplan Cmf, Iplan View, Iplan Spine) K113732
FDA 510(k)
Class IIActive
Vectorvision Trauma K012448
FDA 510(k)
Class IIActive
Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent K003589
FDA 510(k)
Class IIActive
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review K190664
FDA 510(k)
Class IIActive
Patxfer K021583
FDA 510(k)
Class IIActive
Microscope Navigation Software K172820
FDA 510(k)
Class IIActive
Cranial 4Pi Immobilization K243142
FDA 510(k)
Class IIActive
Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine K223553
FDA 510(k)
Class IIActive
Iplan K020631
FDA 510(k)
Class IIActive
Vectorvision Hip K060727
FDA 510(k)
Class IIActive
Exactrac Robotics Novalis Robotics K120520
FDA 510(k)
Class IIActive
Brainscan Conformal Rt Module K971367
FDA 510(k)
Class IIActive
Vectorvision Knee K010612
FDA 510(k)
Class IIActive
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review K170750
FDA 510(k)
Class IIActive
Vv Fluoro 3d K070106
FDA 510(k)
Class IIActive
Drill Guide; Drill Bit; Spine & Trauma Navigation K240701
FDA 510(k)
Class IIActive
Brainlab Knee Arthroscopy K093118
FDA 510(k)
Class IIActive
Brainlab Hip Unlimited, Ci Hip Unlimited K083483
FDA 510(k)
Class IIActive
Kolibri Image Guided Surgery System K042391
FDA 510(k)
Class IIActive
M3 (micro-Multileaf Collimator) K020860
FDA 510(k)
Class IIActive
Vectorvision Ct/Fluoro K010968
FDA 510(k)
Class IIActive
DICOM Viewer K153653
FDA 510(k)
Class IIActive
Vectorvision Hip Sr K063028
FDA 510(k)
Class IIActive
Exactrac (brainlab Patient Positioning System) K983660
FDA 510(k)
Class IIActive
Vectorvision Hip K060468
FDA 510(k)
Class IIActive
Knee 3 K220652
FDA 510(k)
Class IIActive
Ci Tkr/Ukr K031770
FDA 510(k)
Class IIActive
Cranial Image Guided Surgery System K082060
FDA 510(k)
Class IIActive
Hip7 K193307
FDA 510(k)
Class IIActive
Vectorvision Fluoro3d K024192
FDA 510(k)
Class IIActive
Iplan Rt Fibertracking K052220
FDA 510(k)
Class IIActive
Iplan Rt Dose K053584
FDA 510(k)
Class IIActive
Exactrac Gating K033287
FDA 510(k)
Class IIActive
Vector Vision Hip K072716
FDA 510(k)
Class IIActive
Kolibri Spine K042721
FDA 510(k)
Class IIActive
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning K212245
FDA 510(k)
Class IIActive
Brainlab Stereotactic Arc K992916
FDA 510(k)
Class IIActive
Vectorvision Cranial/Ent K023651
FDA 510(k)
Class IIActive
Vectorvision Hip K010602
FDA 510(k)
Class IIActive
Exactrac 3rd Party, Exactrac X-Ray 6d 3rd Party, Exactrac Oem K072046
FDA 510(k)
Class IIActive
Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update K192703
FDA 510(k)
Class IIActive
Cirq Arm System (2.0);Alignment System Spine K222966
FDA 510(k)
Class IIActive

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Brainlab Ltd. PETACH-TIKVA Central · IL FEI 3005225421