BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    Filters Country: Israel ×

    Alfa Gate Mazen Ltd.

    Manufacturer
    🇮🇱 Israel

    GE Medical Systems Israel", Functional Imaging

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

    GE MEDICAL SYSTEMS Israel Ltd.

    Manufacturer
    🇮🇱 Israel

    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

    Aurora

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

    Xeleris V Processing & Review System

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

    StarGuide MDD to MDR Upgrade

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

    StarGuide

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

    MyoSPECT

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

    NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. The NIO-A is intended for adults above 12 years old and the NIO-P is intended for pediatric patients 3 - 12 years of age.

    FDA Enforcement
    Class II ·Terminated·Waismed Ltd·September 7, 2016

    Aurora

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·GE Medical Systems Israel", Functional Imaging·1 device

    StarGuide

    Basic UDI-DI
    EU MDR · Eu Md Class 2b ·GE Medical Systems Israel", Functional Imaging·2 devices

    MyoSPECT

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·GE Medical Systems Israel", Functional Imaging·2 devices

    Xeleris V Processing and Review System

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·GE Medical Systems Israel", Functional Imaging·1 device

    StarGuide

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·GE Medical Systems Israel", Functional Imaging·1 device

    MyoSPECT

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·GE Medical Systems Israel", Functional Imaging·1 device

    7927

    Certificate
    MDD Annex II (excluding section 4)·GE Medical Systems Israel", Functional Imaging·GMED SAS·2 Basic UDI-DIs