8 results
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22ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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Buzz Virtual App
Device
EU MDR
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Eu Md Class 1
·Brainlab AG·On the market
DIOR SW PKG FOR BUZZ VIRTUAL
Device
EU MDR
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Eu Md Class 1
·Brainlab AG·On the market
syngo Virtual Cockpit (VB10A)
FDA 510(k)
FDA Class 2
·Radiology
Buzz Virtual App
Basic UDI-DI
EU MDR
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Eu Md Class 1
·Brainlab AG·2 devices
Navigation Spine & Trauma 3D Version 2.0 and 2.1 Is intended as an intraoperative image-guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or Intraoperative 2D or 3D image data. The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.
FDA Enforcement
Class II
·Terminated·Brainlab AG·August 20, 2014
BrainLAB's VectorVision spine is intended for use as an intraoperative image-guided localization system for minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative image data that is processed by a VectorVision workstation. The system is indicated for any medical condition in which the use of stereoscopic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to a CT, x-ray, or MR-based model of the anatomy.
FDA Enforcement
Class II
·Terminated·Brainlab AG·February 19, 2014
Axxos GmbH
Authorized representative
🇩🇪 Germany·25 Manufacturers·202 Devices
MDSS GmbH
Authorized representative
🇩🇪 Germany·388 Manufacturers·16562 Devices