BEUDAMED
    10,000 results · 58ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Ellipse, Fortify, Fortify Assura, and Quadra Assura MP ICD Devices

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THxID BRAF assay kit

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

    FDA Pre-Market Approval
    FDA Class 3 ·IntellaTip MiFi Open Irrigated

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Thermocool Smart Touch Bi-Directional and Thermocool Smart Touch Electrophysiology

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare Ventricular Assist System

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·Cordis S.M.A.R.T. CONTROL/S.M.A.R.T. Vascular Stent System

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity MRI and Endurity MRI, MRI Activator, and Tendril MRI

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Consulta , Syncra and Viva CRT-P

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·methafilcon B Soft (Hydrophilic) Extended Wear Contact Lenses

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE V EVROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS) & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE PRIME/XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ETI-AB-AUK PLUS ASSAY

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·EVIA DR, EVIA DR-T, EVIA SR, EVIA SR-T, ENTOVIS DR, ENTOVIS DR-T, ENTOVIS SR, ENTOVIS SR-T, ESTELLA DR, ESTELLA DR-T, ES

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards INTUITY Elite Valve System

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Master Restore, Itrel®, Synergy®, IntellisTM and VantaTM Spinal Cord Stimulation Systems and PiscesTM, Specify®, and Vec

    Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

    FDA Pre-Market Approval
    FDA Class 3 ·WOLVERINE™ Coronary Cutting Balloon®

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·Bellafill® Dermal Filler

    Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

    FDA Pre-Market Approval
    FDA Class 3 ·Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D

    Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel