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    Anti-Fya for card method, Coombs-reactive, polyclonal, human

    Device
    EU IVDD · 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 · Eu Ivd Annex 2 List B ·ANTITOXIN GmbH·1 device

    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

    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

    Share Info Consultant Service LLC

    Authorized representative
    🇩🇪 Germany·31 Manufacturers·5861 Devices

    TÜV Rheinland LGA Products GmbH

    Notified body
    🇩🇪 Germany·689 Manufacturers·17345 Basic UDI-DIs

    Caretechion GmbH

    Authorized representative
    🇩🇪 Germany·158 Manufacturers·1463 Devices

    MedPath GmbH

    Authorized representative
    🇩🇪 Germany·537 Manufacturers·13464 Devices