BEUDAMED
    61 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Country: Israel ×

    DPE Medical

    Manufacturer
    🇮🇱 Israel

    DPE MEDICAL LTD.

    FDA registration
    DPE MEDICAL LTD.·1 product·🇮🇱 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

    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

    Venue Go Standard Carts Ref: (H45181VC and H45103VCW), used with Venue Go R2, R3, R4 systems R2, R3, and R4 systems; pulsed doppler imaging system

    FDA Enforcement
    Class II ·Ongoing·GE MEDICAL SYSTEMS, ISRAEL LTD.·October 11, 2023