BEUDAMED
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    Quantidex qPCR BCR-ABL IS Kit

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    BCR-ABL1 (p210) % IS Kit (Digital PCR Method)

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    MRDx BCR-ABL Test, MRDx BCR-ABL Test Software

    FDA 510(k)
    FDA Class 2 ·Medical Genetics

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·ISOLINE 2CR DEFIBRILLATION LEADS

    Alere Afinion HbA1c and ACR on Afinion 2 analyzer

    FDA 510(k)
    FDA Class 2 ·Hematology

    AptiVue™

    FDA UDI
    ST. JUDE MEDICAL, INC.·05415067030108·Software Upgrade Kit

    Tigereye

    FDA UDI
    AVINGER, INC.·00851354004493·The Tigereye System is intended to facilitate t...

    Tigereye ST

    FDA UDI
    AVINGER, INC.·00851354004554·The Tigereye ST System is intended to facilitat...

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·LINOX SMART SD, VIGILA 1CR, VOLTA 1CR, LINOX SMART S DX, PROTEGO SD

    SUPRAMID EXTRA

    FDA UDI
    S JACKSON INC·00816848020007·Straight Taper Point (19mm), USP 3-0 SUPRAMID E...

    SUPRAMID EXTRA

    FDA UDI
    S JACKSON INC·00816848020014·Straight Taper Point (19mm), USP 4-0 SUPRAMID E...

    COR-VALV Atrial retractor

    Device
    EU MDD · Eu Md Class 2a ·Coroneo Inc.·On the market·11 countries

    CoCr Scan abutment Standard

    Device
    EU MDR · Eu Md Class 1 ·IMPLANT PROTESIS DENTAL 2004 S.L.·On the market·22 countries

    BT 1500 C/BCR

    Device
    EU IVDR · Eu Ivd Class A ·Biotecnica Instruments S.r.l.·On the market·32 countries

    BT 1500 C/BCR

    Device
    EU IVDR · Eu Ivd Class A ·Biotecnica Instruments S.r.l.·On the market·32 countries

    BT 1500 C/BCR

    Device
    EU IVDR · Eu Ivd Class A ·Biotecnica Instruments S.r.l.·On the market·32 countries

    BT 1500 C/BCR

    Device
    EU IVDR · Eu Ivd Class A ·Biotecnica Instruments S.r.l.·On the market·32 countries

    BT 1500 C/BCR

    Device
    EU IVDR · Eu Ivd Class A ·Biotecnica Instruments S.r.l.·On the market·32 countries

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·VOLTA(1CR/2CR/CT/2CT) ICD LEAD, PROTEGO (S/SD/T/TD) ICD LEAD,KAINOX VCS 60 ICD LEADLINOX SMART (S/SD/T/TD/S DX) ICD LEAD