BEUDAMED
    63 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Cancer-Related Germline Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·myChoice HRD CDx

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·myChoice CDx

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·myChoice CDx

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ACUITY SPIRAL, EASYTRAK 2 LV-1, EASYTRAK 2 IS-1, EASYTRAK 3 LV-1, EASYTRAK 3 IS-1

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EASYTRAK 2 LV-1, IS-1, 3 LV-1, 3 IS-1 LEFT VENTRICLAR HEART FAILURE LEADS, AND ACUITY SPIRAL LEADS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EASYTRAK 3 IS-1 LEADS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EASYTRAK 2 IS-1 LEAD

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EASYTRAK 3 IS-1 & LV-1

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·ACUITY SPIRAL AND EASYTRAK 3 IS-1 LEADS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EASYTRAK 3 IS-1 LEAD MODELS: 4548/4549/4550

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EASYTRAK 3 IS-1 & LV-1 HEART FAILURE LEADS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EASYTRAK 2 IS-1 CORONARY VENOUS BIPOLAR PACE/SENSE LEADS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EASYTRAK 3 IS-1 AND LV-1 HEART FAILURE LEADS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·RELIANCE IS-1/IS-4 ACTIVE AND PASSIVE FIXATION DEFIBRILATION LEADS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·EASYTRAK 2+ IS-1 CORONARY VENOUS STEROID ELUTING DUAL ELECTRODE PACE/SENSE LEADS

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·VISIONS MADE WITH PARAGON HDS (PAFLUFOCON B)

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BOSTON EQUALENS, EQUALENS II (ITAFLUROFOCON A)& (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Paragon CRT (paflufocon B), Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) and Paragon RG-4 (paflu

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS