8 results
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16ms
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Sources: EU EUDAMED, US FDA
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Country: Germany
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Anti-Fya for card method, Coombs-reactive, polyclonal, human
Device
EU IVDD
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Eu Ivd Annex 2 List B
·ANTITOXIN GmbH·On the market
Anti-Fya for card method, Coombs-reactive, polyclonal, human
Basic UDI-DI
EU IVDD
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Eu Ivd Annex 2 List B
·ANTITOXIN GmbH·1 device
Samet Kaya & Burak Kaya GbR
Importer
🇩🇪 Germany
pricon GmbH & Co.KG
Importer
🇩🇪 Germany·2 Manufacturers
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
Trusetal Verbandstoffwerk GmbH
Importer
🇩🇪 Germany·9 Manufacturers
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
MedNet EC-REP GmbH
Authorized representative
🇩🇪 Germany·464 Manufacturers·5263 Devices