BEUDAMED
    17 results · 19ms · Sources: EU EUDAMED, US FDA

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    HOYA Holdings NV

    Manufacturer
    🇩🇪 Germany

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

    Device
    EU IVDD · Eu Ivd Annex 2 List B ·ANTITOXIN GmbH·On the market

    Gründler GmbH

    Manufacturer
    🇩🇪 Germany·2 Basic UDI-DIs·2 Devices·SGS FIMKO OY

    Fiagon GmbH

    Manufacturer
    🇩🇪 Germany·14 Basic UDI-DIs·33 Devices·SGS FIMKO OY

    PAUSCH Medical GmbH

    Manufacturer
    🇩🇪 Germany·SGS FIMKO OY

    Rhyk Technologies GmbH

    Manufacturer
    🇩🇪 Germany·SGS FIMKO OY

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

    Basic UDI-DI
    EU IVDD · Eu Ivd Annex 2 List B ·ANTITOXIN GmbH·1 device

    HOYA Surgical Optics GmbH

    Authorized representative
    🇩🇪 Germany·1 Manufacturer

    PENTAX Europe GmbH

    Authorized representative
    🇩🇪 Germany·4 Manufacturers·142 Devices

    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

    PENTAX Europe 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

    FI24/00000064

    Certificate
    MDR QMS·Fiagon GmbH·SGS FIMKO OY

    FI23/00000052

    Certificate
    MDR QMS·PAUSCH Medical GmbH·SGS FIMKO OY

    FI23/00000046

    Certificate
    MDR QMS·Rhyk Technologies GmbH·SGS FIMKO OY

    FI23/00000013

    Certificate
    MDR QMS·Gründler GmbH·SGS FIMKO OY

    Caretechion GmbH

    Authorized representative
    🇩🇪 Germany·158 Manufacturers·1463 Devices