BEUDAMED
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    ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS

    FDA 510(k)
    FDA Class 2 ·Radiology

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·COROX OTW (-S) BP STEROID-ELUTING LEADS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·SELOX SR/ST/JT, SETROX S, AND DEXTRUS STEROID-ELUTING LEADS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·KENTROX SL/SL-S/RV/RV-S & LINOX S/SD/T/TD STEROID-ELUTING LEADS

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·COROX OTW UP STEROID-ELUTING LEAD

    AC-ADAPTER-E1600 (HXA-AC-1300E)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·9 countries

    GS CUFF2 XL (HXA-GCFXL-PBE)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·22 countries

    GS CUFF2 L (HXA-GCFL-PCE)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·5 countries

    GS CUFF2 L (HXA-GCFL-PBE)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·16 countries

    GS CUFF2 M (HXA-GCFM-PBE)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·12 countries

    GS CUFF2 S (HXA-GCFS-PCE)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·1 country

    GS CUFF2 S (HXA-GCFS-PBE)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·22 countries

    GS CUFF2 SS (HXA-GCFSS-PCE)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·5 countries

    GS CUFF2 SS (HXA-GCFSS-PBE)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·24 countries

    GS CUFF SS (HXA-GCUFF-SSLB)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·9 countries

    GS CUFF2 XL (HXA-GCFXL-PCE)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·5 countries

    GS CUFF2 M (HXA-GCFM-PCE)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·8 countries

    GS CUFF L (HXA-GCUFF-LLB)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·9 countries

    GS CUFF XL (HXA-GCUFF-XLLB)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·14 countries

    GS CUFF M (HXA-GCUFF-MLB)

    Device
    EU MDR · Eu Md Class 1 ·OMRON Healthcare Co., Ltd.·On the market·10 countries