FDA.report

BRAINLAB SE

Matched from indexed company URL: Brainlab SE

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
80439333002619595BRAINLAB SE1N2026-01-01Olof-Palme-Strasse 9 Munich Bavaria DE 81829

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
04056481141981HIP7 - 7.0+4989991568contact@brainlab.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
449921638470623K994413BRAINSCANMUJ2000-07-13
449921875476987K983660EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM)LHN1999-07-14
449921065928450K954861BRAINLAB CT/X-RAY LOCALIZERIYE1996-08-05
449921310991056K954789BRAINLAB HEADPINSHAW1996-08-12
449921170717672K952390BRAINLAB STEROTATIC HEADRINGHAW1996-02-02
449921669196971K945903BRAINLAB MASK SYSTEMIYE1995-06-05
449921096450714K934657BRAINLAB LINAC HARDWAREIYE1994-07-22
449921115536198K254010ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceIYE2026-01-14
449921226881728K252562Spine & Trauma Navigation InstrumentsOLO2025-09-12
449921609754679K252476Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutLLZ2025-10-16
449921552272676K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS; (Elements) Spine SRS; (Elements) Cranial SRS w/ Cones; (Elements) RT Planning Platform; (Elements) Dose Review; (Elements) Retreatment Review; Elements Segmentation [Cranial , Basal Ganglia, Head & Neck, Pelvic, Spine, Thoracic & Spine, Extracranial] RT; Elements AI Tumor Segmentation RT; Elements SmartBrush [Angio, Spine] RT; Elements Object Management RTMUJ2025-06-17
449921119711227K243698Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITTHAW2025-01-28
449921899343421K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0)QIH2025-06-13
449921011749890K243432Vascular Navigation PAD 2.0; Navigation Software Vascular PADOWB2025-07-22
449921064026045K243142Cranial 4Pi ImmobilizationIYE2025-06-23
449921028883513K242569Mixed Reality Spine NavigationSBF2025-05-16
449921119961598K240701Drill Guide; Drill Bit; Spine & Trauma NavigationOLO2024-05-23
449921481155578K240431ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceIYE2024-07-24
449921086326156K234068ART-Plan (v.2.2.0)MUJ2024-04-22
449921748757914K234067ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)OWB2025-03-28
449921853282046K234047Automatic RegistrationOLO2024-03-20
449921049704603K232759Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart LayoutLLZ2024-05-21
449921935509212K232479ART-PlanMUJ2023-12-22
449921751933229K231498TraumaCad NeoLLZ2023-11-20
449921531308402K231052ExacTrac Dynamic 1.1.2IYE2023-05-11
449921495377965K230201Disposable Pre-calibrated Brain Biopsy Needle 2.0HAW2023-02-22
449921384484077K230023ART-PlanQKB2023-04-19
449921847166749K223864Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software CranialHAW2023-09-09
449921817638413K223734ENT EMPGW2023-04-27
449921409389943K223553Spine Planning (2.0), Elements Spine Planning, Elements Planning SpineOLO2023-08-02
449921414501862K223552Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning CranialHAW2023-04-19
449921853916061K223288Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRIHAW2023-07-21
449921006249190K223279RT Elements (4.0)MUJ2023-03-14
449921389299844K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking (2.0);BOLD MRI Mapping (1.0);Image Fusion Angio (1.0)QIH2023-07-14
449921168576351K222966Cirq Arm System (2.0);Alignment System SpineOLO2022-10-27
449921958386307K221618Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm SystemOLO2022-08-30
449921449825046K220338ExacTrac DynamicIYE2022-04-29
449921107985796K213989Cranial EM SystemHAW2022-09-08
449921679078851K213930Brainlab Elements Guide XT, Guide 3.0QQC2022-04-19
449921790604145K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion AngioLLZ2021-12-16
449921501024524K212245Spine 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 PlanningOLO2022-04-13
449921813654690K211939ExacTrac DynamicIYE2021-07-22
449921906842527K211544Trajectory Planning, Elements Trajectory Planning, Elements Lead LocalizationHAW2021-11-03
449921216737367K210989Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine SystemHAW2021-11-12
449921933235059K203681RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose ReviewMUJ2021-04-09
449921084166133K203679Automatic RegistrationOLO2021-03-18
449921873417142K203281Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-XOWB2020-12-22
449921373787916K203173ExacTrac DynamicIYE2020-11-12
449921164111096K202320CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine SystemOLO2020-12-23
449921947301888K202050Cranial 4Pi ImmobilizationIYE2020-08-19
449921614472026K201752Disposable Pre-calibrated SuctionHAW2021-01-29
449921859165584K192703Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure UpdateHAW2020-10-08
449921138618447K191285Spine & Trauma NavigationOLO2019-06-11
449921701987033K191014Elements ViewerLLZ2020-01-23
449921236688995K190887Leksell Vantage Stereotactic SystemHAW2019-08-01
449921512435847K190664RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose ReviewMUJ2019-04-12
449921012050354K190250Microscope NavigationHAW2019-09-06
449921915977706K190042Brainlab Elements Image Fusion AngioLLZ2019-04-25
449921602452182K183605Spine & Trauma NavigationOLO2019-08-29
449921337712672K180393AIRO Computed Tomography (CT) X-ray SystemJAK2018-03-15
449921414758643K173381Nexxis ORDXJ2018-02-22
449921643655548K172820Microscope Navigation SoftwareHAW2018-03-01
449921228871943K171123Leksell Vantage Stereotactic SystemHAW2017-09-15
449922061066806K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAMLLZ2017-09-26
449921619258400K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose ReviewMUJ2017-08-24
449921393676116K163505ARIETTA PRECISIONIYN2017-05-30
449921773252049K153653DICOM ViewerLLZ2016-04-13
449921645773011K152558Leksell Stereotactic System, Injection/ Aspiration Needle KitHAW2016-03-02
449921630749735K142647mint LesionLLZ2015-04-13
449921214512757K142108RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSISMUJ2014-12-16
449922045561630K141199QUENTRY DOSE REVIEWLLZ2014-06-20
449922033357960K132763ADVANCED VIEWERLLZ2014-02-28
449921719169779K132436VARIOGUIDE DRILL KITHBE2014-03-20
449921900865028K131431AIRO CT SYSTEMJAK2013-09-26
449921755235160K123788INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)IYE2013-01-15
449921771593014K123605SMARTFLOW CATHETERHCA2013-08-16
449921477328807K122451EXACTRAC VEROIYE2012-09-28
449921930424407K122450MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVISIYE2012-10-03
449921229892092K122225STERILE RADIOLUCENT SKULL PINSHBL2013-04-26
449921158938991K122167NEXXIS ORDXJ2013-04-22
449921376661991K122011NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAPOLO2012-11-15
449921025226254K120789EXACTRAC X-RAY X-RAYIYE2012-08-14
449921729176529K120520EXACTRAC ROBOTICS NOVALIS ROBOTICSJAI2012-06-29
449921681300871K113732IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)JAK2012-05-07
449921177933590K112881NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)GWF2012-05-22
449921141887059K110204BRAINLAB TRAUMAOLO2011-08-05
449921148671107K110021DASH HIPOLO2011-10-18
449921146849705K103246IPLAN RTMUJ2011-03-16
449921305949866K102990BRAINLAB KNEEOLO2011-04-04
449921118580547K102251DASH KNEEOLO2011-05-17
449922034073263K101627IPLANHAW2011-06-03
449921052369805K100038DISPOSABLE REFLECTIVE MARKER SPHERESHAW2010-07-14
449921625654866K093118BRAINLAB KNEE ARTHROSCOPYOLO2010-06-11
449922044797809K093117DIGITAL LIGHTBOXLLZ2009-12-11
449922002311977K092467VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITEDHAW2010-05-06
449921531505130K083912TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINSHWC2009-07-15
449921158619732K083483BRAINLAB HIP UNLIMITED, CI HIP UNLIMITEDOLO2009-04-08
449921365916161K083310SPINE & TRAUMA ICTOLO2009-04-01
449921028623216K082060CRANIAL IMAGE GUIDED SURGERY SYSTEMHAW2009-05-08
449921393538334K080888MODEIFICATION TO IPLAN RT DOSEMUJ2008-06-11
449921798214929K080886IPLAN RT IMAGELHN2008-06-24
449921031023358K080678UNI-KNEE 2.0HAW2008-06-06
449921230352378K080608DIGITAL LIGHTBOXLLZ2008-04-17
449921572411094K073714TRAUMACAD VERSION 2.0LLZ2008-03-19
449921887964670K073615BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITEDHAW2008-09-05
449921080512293K073018STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHTIYE2008-01-23
449921231002123K072716VECTOR VISION HIPHAW2007-10-12
449921267341990K072573VECTORVISION HIP AND HIP SRHAW2007-10-11
449921141362878K072506EXACTRAC 5.5IYE2007-10-26
449921277372957K072047MHI-TM2000 LINEAR ACCELERATOR SYSTEMIYE2007-08-29
449921721072811K072046EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEMIYE2007-10-17
449921099004483K070556BRAINSUITE NETHAW2007-09-25
449921432689562K070106VV FLUORO 3DHAW2007-04-23
449921965102019K063494DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTSHBL2007-05-21
449921420616911K063028VECTORVISION HIP SRHAW2006-12-12
449921335620854K062358MODIFICATION TO VECTORVISION TRAUMAHAW2007-01-17
449921479482126K060808BRAINPRO, BRAINPRO ACCESSHAW2006-07-25
449921775954934K060727VECTORVISION HIPHAW2006-08-21
449921590323196K060468VECTORVISION HIPHAW2006-03-20

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
HAW552025-01-28
IYE252026-01-14
OLO192025-09-12
LLZ162025-10-16
MUJ122025-06-17
OWB32025-07-22
JAK32018-03-15
QIH22025-06-13
DXJ22018-02-22
HBL22013-04-26
JAI22012-06-29
LHN22008-06-24
SBF12025-05-16
PGW12023-04-27
QKB12023-04-19
QQC12022-04-19
IYN12017-05-30
HBE12014-03-20
HCA12013-08-16
GWF12012-05-22
HWC12009-07-15
GZL12004-08-20

GUDID