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Brainlab AG

DE

Last updated September 17, 2026

Information

Country
DE
Address
—
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 3 of 5
DeviceModel / ReferenceRegistriesClassStatus
DICOM Proxy 4.0 4.0
FDA UDI
Class IUnknown
RT QA Element 1.0
FDA UDI
Class IIUnknown
Drill Bit 3.2 mm Depth Control (200 mm) 41839-37
FDA UDI
Class IIActive
Sterilization Tray Standards Cranial Accessories 52315
FDA UDI
Class IUnknown
Couchmount Lite Siemens 40200-5
FDA UDI
Class IIUnknown
Us- Adapter Siemens Sonoline 5P10 41860-23
FDA UDI
Class IIUnknown
Exactrac 48370
FDA UDI
Class IIUnknown
RT Elements - Multiple Brain Mets SRS 2.0
FDA UDI
Class IIActive
Headpins 41562-1
FDA UDI
Class IIUnknown
4 In1 Cut Block Temp Exactech Optetrack 52473
FDA UDI
Class IIUnknown
Sterilization Tray Hip Resurfacing 52310
FDA UDI
Class IUnknown
Fluoro Registration Kit (Rev.2) 55705
FDA UDI
Class IIUnknown
Kick® Em 18090
FDA UDI
Class IIUnknown
Ultrasound Clamp Acuson V7 41860-15
FDA UDI
Class IIUnknown
Igs Handle Softgrip 'Gearshift' 55830-10A
FDA UDI
Class IIUnknown
Reference Star Iop Imaging 19145-01
FDA UDI
Class IIUnknown
Spine Srs 1.5
FDA UDI
Class IIActive
Skull Reference Base 52129A
FDA UDI
Class IIActive
Guide 3.4 Biopsy Ui 55993-01
FDA UDI
Class IIUnknown
Patient Data Manager 2.5
FDA UDI
Class IIUnknown
Gauge BL Pointer, Sharp Tip Extended 52780-10
FDA UDI
Class IActive
Adj Cutb - Adj Unit 53210A
FDA UDI
Class IIUnknown
4 In 1 Cutting Block Template ''Smith & 41838
FDA UDI
Class IIUnknown
Disp. Registration Marker Or 52152A
FDA UDI
Class IIUnknown
Us- Adapter Siemens Sonoline C8-5 41860-24
FDA UDI
Class IIUnknown
Steri Tray Express Ref.Fixation Knee 54920
FDA UDI
Class IIUnknown
Pointer Tip (Offset 45°, Length 115 Mm) 55791-02
FDA UDI
Class IIUnknown
Clearlens Knee Plane Tool - Interface 53238
FDA UDI
Class IIUnknown
Patella Tracking Array 52466A
FDA UDI
Class IIUnknown
Stem Verification Tool Hip Ct 52872B
FDA UDI
Class IIUnknown
Navigation Sw Hip 3.1 On Ci K052213
FDA 510(k)
Class IIActive
Brainsuite Net K070556
FDA 510(k)
Class IIActive
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System K221618
FDA 510(k)
Class IIActive
ExacTrac Dynamic 1.1.2 K231052
FDA 510(k)
Class IIActive
Vectorvision Acl K042512
FDA 510(k)
Class IIActive
Novalis (shaped Beam Surgery System) K002509
FDA 510(k)
Class IIActive
Navigation Software Hip-Universal; Navigation Software Hip Thr-Aesculap K122011
FDA 510(k)
Class IIActive
Brainscan Brachytherapy Module K920880
FDA 510(k)
Class IIActive
Iplan K101627
FDA 510(k)
Class IIActive
Stereotactic Target Positioner, Target Positioner For Leksell Headring, Stereotactic Counterweight K073018
FDA 510(k)
Class IIActive
@ Target K983410
FDA 510(k)
Class IIActive
Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout K232759
FDA 510(k)
Class IIActive
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review K203681
FDA 510(k)
Class IIActive
Sterile Radiolucent Skull Pins K122225
FDA 510(k)
Class IIActive
Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization K211544
FDA 510(k)
Class IIActive
Modification To: Vectorvision Frameless Biopsy System K012564
FDA 510(k)
Class IIActive
Vectorvision Ct-Free Knee K021306
FDA 510(k)
Class IIActive
Cranial EM System K213989
FDA 510(k)
Class IIActive
Brainscan K994413
FDA 510(k)
Class IIActive
Spine & Trauma Ict K083310
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