BEUDAMED
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    URIN. L7-OH CORTICOSTEROID T(NON HYDRO)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Immunohistochemistry Antibody Assay, C-Kit

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-C-KIT (9.7) PRIMARY ANTIBODY

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

    Drug-Eluting Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Lutonix 035 DCB PTA Catheter Balloon

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·VENTAK AV DDD/AV II DDDD

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·GAMMA DAB (125I) AFP RIA KIT

    DAB Chromogen kit, for 1250 tests

    Device
    EU IVDR · Eu Ivd Class A ·BioGnost Ltd.·On the market·32 countries

    DAB Chromogen kit, for 250 tests

    Device
    EU IVDR · Eu Ivd Class A ·BioGnost Ltd.·On the market·32 countries

    Titan HRP DAB 30 mL Kit

    Device
    EU IVDR · Eu Ivd Class A ·Lumatas BioSystems Inc·On the market·32 countries

    005 PolyQ Stain DAB Substrate Buffer

    Device
    EU IVDR · Eu Ivd Class A ·biocyc Biotechnologie GmbH & Co. KG·On the market

    HS Fiber

    FDA UDI
    RIVERPOINT MEDICAL, LLC·00812444025064·Suture

    System, Test, Her-2/Neu, Ihc

    FDA Pre-Market Approval
    FDA Class 3 ·PATHWAY ANTI-HER-2/NEU (4B5) RABBIT MONOCLONAL PRIMARY ANTIBODY

    Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

    FDA Pre-Market Approval
    FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

    Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

    FDA Pre-Market Approval
    FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

    Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only)

    FDA Pre-Market Approval
    FDA Class 2 ·MODEL 4553 DUAL CHAM. DDD TEMP.CARDIAC PACEMAKER

    FDA Pre-Market Approval
    VENTAK AV DDD FAMILY OF AICD SYSTEMS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·DELTA PACEMAKER SYS; VIGOR DDD MODEL 950

    FDA Pre-Market Approval
    VENTAK AV DDD FAMILY OF AICD SYSTEMS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·AUTIMA PACING SYSTEM (META DDD MODEL 1230)