Brainlab AG

FDA Filings

This page includes the latest FDA filings for Brainlab AG. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Brainlab AG
Elements Viewer2020-01-23
Brainlab AG
Microscope Navigation2019-09-06
Brainlab AG
Spine & Trauma Navigation2019-08-29
Brainlab AG
Spine & Trauma Navigation2019-06-11
Brainlab AG
Brainlab Elements Image Fusion Angio2019-04-25
Brainlab AG
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review2019-04-12
Brainlab AG
Microscope Navigation Software2018-03-01
Brainlab AG
Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM2017-09-26
Brainlab AG
RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review2017-08-24
Brainlab AG
Dicom Viewer2016-04-13
BRAINLAB AG
Rt Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery Analysis2014-12-16
BRAINLAB AG
Quentry Dose Review2014-06-20
BRAINLAB AG
STERILE RADIOLUCENT SKULL PINS2013-04-26
BRAINLAB AG
NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP2012-11-15
BRAINLAB AG
EXACTRAC VERO2012-09-28
BRAINLAB AG
EXACTRAC X-RAY X-RAY2012-08-14
BRAINLAB AG
EXACTRAC ROBOTICS NOVALIS ROBOTICS2012-06-29
BRAINLAB AG
IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE)2012-05-07
BRAINLAB AG
BRAINLAB TRAUMA2011-08-05
BRAINLAB AG
Iplan2011-06-03
BRAINLAB AG
Dash Knee2011-05-17
BRAINLAB AG
BRAINLAB KNEE2011-04-04
BRAINLAB AG
Brainlab Knee Arthroscopy2010-06-11
BRAINLAB AG
VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED2010-05-06
BRAINLAB AG
Digital Lightbox2009-12-11
BRAINLAB AG
BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED2009-04-08
BRAINLAB AG
BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED2008-09-05
BRAINLAB AG
IPLAN RT IMAGE2008-06-24
BRAINLAB AG
UNI-KNEE 2.02008-06-06
BRAINLAB AG
BRAINSUITE NET2007-09-25

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
INSTRUMENT ADAPTER EXTENSION 50 MM
Brainlab AG2020-02-10
INSTR ADAPTER CLAMP SIZE XL (Softgrip)
Brainlab AG2020-02-10
INSTR ADAPTER CLAMP SIZE L (Softgrip)
Brainlab AG2020-02-10
Sterilization Tray Trauma / Knee Arthroscopy
Brainlab AG2020-02-10
Sterilization Tray Adjustable Cutting Block
Brainlab AG2020-02-06
Instr. Adp Offset-Link 45° 20Mm Starlink
Brainlab AG2020-02-03
Sterilization Tray Spine Instruments
Brainlab AG2020-01-20
Sterililzation Tray Trauma Instruments
Brainlab AG2020-01-20
Sterilization Tray DrapeLink for C-arm
Brainlab AG2020-01-20
Sterilization Tray For Drill Guide Long
Brainlab AG2020-01-20
Cranial IGS System Automatic Registration iMRI
Brainlab AG2020-01-20
Sterilization Tray Spine Basic/Universal
Brainlab AG2020-01-20
Sterilization Tray Manual Spinal Drilling Cirq
Brainlab AG2020-01-20
Sterilization Tray Handheld Registration Device for Fluoro 2D
Brainlab AG2020-01-20
Automatic Registration Matrix iMRI
Brainlab AG2020-01-16
Reference Adapter Drapelink for Auto-Registration iMRI
Brainlab AG2020-01-16
STERILIZATION TRAY SPINE BASIC/MIS/UNIV
Brainlab AG2020-01-10
Microscope Universal Tracking Array
Brainlab AG2019-12-23
Mechanical Arm Adapter for Instrument Holder
Brainlab AG2019-12-16
Reference Array Spine, Marker Disks
Brainlab AG2019-12-12
Drill Guide Tube 3.2 mm X 200 mm
Brainlab AG2019-12-12
Drill Guide Tube 2.6 mm X 200 mm
Brainlab AG2019-12-12
Drill Guide Depth Control (200 mm)
Brainlab AG2019-12-12
Drill Bit 3.2 mm Depth Control (200 mm)
Brainlab AG2019-12-12
Drill Bit 2.6 mm Depth Control (200 mm)
Brainlab AG2019-12-12
Drill Guide Handle 4-Marker
Brainlab AG2019-12-12
Scanner Reference Adapter Bodytom
Brainlab AG2019-12-12
Igs Handle Softgrip 'Universal'
Brainlab AG2019-12-12
Drill Guide Insertable Depth Control
Brainlab AG2019-12-12
DRILL GUIDE COMPACT HANDLE 4 MARKERS
Brainlab AG2019-12-12
Pedicle Access Guide Tube
Brainlab AG2019-12-12
Drill Guide Tube 2.4 X 150 mm
Brainlab AG2019-12-12
Drillguide Tube 4.5mm
Brainlab AG2019-12-12
Drill Guide Tube 2.6 X 150 mm
Brainlab AG2019-12-12
Drill Guide Tube 3.2 X 150 mm
Brainlab AG2019-12-12

Related Finance Registrations
Legal Entity Identifier LZL5OMI84ZIT44MHOH61 [Brainlab AG]

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