BEUDAMED
    1,459 results · 21ms · Sources: EU EUDAMED, US FDA

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    GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 / 5842894-20, e) 830 / Dismount / 50HZ, f) 830 / Dismount / 60HZ, g) 830 3/8 inch Detector, h) 830 BJ, i) 830 BJ / 5144407, j) 830 BJ / Dismount, k) 830 ES DEM, l) 830 NM Cyber Defense Configuration Gantry 3/8 inch, m) 830 NM Gantry 3/8 inch, n) 830 NM Gantry 5/8 inch, o) 870 DR NM GANTRY FINAL - NEW ROTOR, p) B615 to D630 UPG, q) D630 NM GANTRY, r) D630 NM GANTRY 3/8 inch WITH NEW ROTOR - MEA, s) D630 NM Gantry 3/8 inch, t) D630 NM GANTRY FINAL ASSEMBLY_, u) D630 with new rotor, v) D630 with new rotor/ 5144407 / Dismount, w) D630 with new rotor/ Dismount, x) DISCOVERY D630 X 3/8 inch, y) DISCOVERY D630 X 3/8 inch, z) DISCOVERY D630 X 3/8 inch, aa) DISCOVERY D630 x 3/8 inch BHW, bb) DISCOVERY D630 X 3/8 inch BJG, cc) DISCOVERY D630 X 3/8 inch MEA, dd) DISCOVERY NM 830 3/8 inch, ee) DISCOVERY NM 830 3/8 inch, ff) NM 830 3/8 inch, gg) NM 830 3/8 inch BJ, hh) NM 830 ES, ii) NM DISCOVERY D630 3/8 inch, jj) NUC GOLDSEAL D630 X 3/8 inch. Emission Computed Tomography System

    FDA Enforcement
    Class I ·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023

    Accurate Medical Therapeutics Ltd.

    Manufacturer
    🇮🇱 Israel·1 Importer

    GE Medical Systems Israel", Functional Imaging

    Manufacturer
    🇮🇱 Israel·6 Basic UDI-DIs·8 Devices·GMED SAS

    GE MEDICAL SYSTEMS Israel Ltd.

    Manufacturer
    🇮🇱 Israel

    Carolina Lemke Ltd

    Manufacturer
    🇮🇱 Israel

    Spectrum Dynamics Medical ltd

    Manufacturer
    🇮🇱 Israel·4 Basic UDI-DIs·12 Devices

    CT/GAMMA CAMERA SYSTEMS

    Device
    EU MDR · Eu Md Class 2b ·GE Medical Systems Israel", Functional Imaging·On the market·32 countries

    MyoSPECT ES

    Device
    EU MDR · Eu Md Class 2a ·GE Medical Systems Israel", Functional Imaging·On the market·32 countries

    MyoSPECT

    Device
    EU MDR · Eu Md Class 2a ·GE Medical Systems Israel", Functional Imaging·On the market·23 countries

    VERITON CT 464

    Device
    EU MDR · Eu Md Class 2b ·Spectrum Dynamics Medical ltd·On the market·5 countries

    VERITON CT 416

    Device
    EU MDR · Eu Md Class 2b ·Spectrum Dynamics Medical ltd·On the market·5 countries

    VERITON CT 364

    Device
    EU MDR · Eu Md Class 2b ·Spectrum Dynamics Medical ltd·On the market·6 countries

    VERITON CT 316

    Device
    EU MDR · Eu Md Class 2b ·Spectrum Dynamics Medical ltd·On the market·2 countries

    VERITON CT 264

    Device
    EU MDR · Eu Md Class 2b ·Spectrum Dynamics Medical ltd·On the market·5 countries

    VERITON CT 216

    Device
    EU MDR · Eu Md Class 2b ·Spectrum Dynamics Medical ltd·On the market·6 countries

    VERITON NM 300

    Device
    EU MDR · Eu Md Class 2a ·Spectrum Dynamics Medical ltd·On the market·3 countries

    VERITON NM 400

    Device
    EU MDR · Eu Md Class 2a ·Spectrum Dynamics Medical ltd·On the market·1 country

    VERITON NM 200

    Device
    EU MDR · Eu Md Class 2a ·Spectrum Dynamics Medical ltd·On the market·6 countries

    TruSPECT

    Device
    EU MDR · Eu Md Class 2b ·Spectrum Dynamics Medical ltd·On the market·7 countries

    Aurora

    Device
    EU MDR · Eu Md Class 2b ·GE Medical Systems Israel", Functional Imaging·On the market·2 countries