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BRAINLAB SE

FDA registration
BRAINLAB SE·37 products·🇩🇪 Germany

Brainlab AG

Manufacturer
🇩🇪 Germany·91 Basic UDI-DIs·264 Devices·TÜV SÜD Product Service GmbH and TÜV SÜD Product Service GmbH

Brainlab Robotics GmbH

Manufacturer
🇩🇪 Germany

Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio

FDA 510(k)
FDA Class 2 ·Radiology

Brainlab 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)

FDA 510(k)
FDA Class 2 ·Radiology

BRAINLAB TRAUMA

FDA 510(k)
FDA Class 2 ·Neurology

BRAINLAB KNEE

FDA 510(k)
FDA Class 2 ·Neurology

BRAINLAB KNEE ARTHROSCOPY

FDA 510(k)
FDA Class 2 ·Neurology

BRAINLAB MASK SYSTEM

FDA 510(k)
FDA Class 2 ·Radiology

BRAINLAB STEROTATIC HEADRING

FDA 510(k)
FDA Class 2 ·Neurology

BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED

FDA 510(k)
FDA Class 2 ·Neurology

HEX SCREWDRIVER T-HANDLE (2.5 MM)

Device
EU MDR · Eu Md Class 1 ·Brainlab AG·On the market

HANDLE UNIVERSAL FOR OPEN SURGERY

Device
EU MDR · Eu Md Class 1 ·Brainlab AG·On the market

HEX SCREWDRIVER BALL-END (2.5 MM)

Device
EU MDR · Eu Md Class 1 ·Brainlab AG·On the market

HANDLE GEARSHIFT FOR OPEN SURGERY

Device
EU MDR · Eu Md Class 1 ·Brainlab AG·On the market

Disposable Clip-on Remote Control

Device
EU MDR · Eu Md Class 1 ·Brainlab AG·On the market

Disposable Clip-on Remote Control

Device
EU MDR · Eu Md Class 1 ·Brainlab AG·On the market

Sterilization Tray VarioGuide® Alignment System

Device
EU MDR · Eu Md Class 1 ·Brainlab AG·On the market

Sterilization Tray VarioGuide® Alignment System

Device
EU MDR · Eu Md Class 1 ·Brainlab AG·On the market

STERILIZATION TRAY VARIOGUIDE® ALIGMENT SYSTEM

Device
EU MDR · Eu Md Class 1 ·Brainlab AG·On the market