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

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    630.00 scissors gfx curved 13cm

    Device
    EU MDR · Eu Md Class 1 ·Prodont-Holliger·On the market

    408.05SI scaler double gfx 21 xl

    Device
    EU MDR · Eu Md Class 1 ·Prodont-Holliger·On the market

    406.05SI scaler double gfx 1 xl

    Device
    EU MDR · Eu Md Class 1 ·Prodont-Holliger·On the market

    GLX

    Importer
    🇫🇷 France

    The EOSedge system may acquire two simultaneous orthogonal planar images for a standing or seated patient at low dose. The scan length is defined by the user and may cover the whole body or a specific area (spine, lower limbs, etc.). EOSedge consists of a gantry and an acquisition workstation. ¿ The gantry contains two orthogonal acquisition units, each of which comprises an X-ray source (high frequency generator + X-ray tube + collimator) and an X-ray detection system (detector + electronics). ¿ The acquisition workstation and its software control the generators and detectors. It is also used to enter patient data, via RIS/HIS or manually, to define acquisition parameters, process images and record images in DICOM 3.0 format. The intended use/indications for use, technological characteristics, and principles of operation of the EOSedge system are described below.

    FDA Enforcement
    Class II ·Terminated·EOS Imaging·April 21, 2021

    TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S

    FDA Enforcement
    Class II ·Terminated·NewDeal SA·July 25, 2018