BEUDAMED
    10,000 results · 24ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·Cardiac Resynchronization Therapy (CRT)

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Perclose ProStyle Suture-Mediated Closure and Repair System, Perclose ProGlide Suture-Mediated Closure System

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS, MODELS 305, 310

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX,6900, 6900P

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·DURATA FAMILY OF HIGH VOLTAGE LEADS

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

    FDA Pre-Market Approval
    FDA Class 3 ·EPIC II HF & ATLAS II HF CRT-DS

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+ familyof ICD's

    Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

    FDA Pre-Market Approval
    FDA Class 3 ·Implantable Pluse Generator (IPG): Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·Resolute Onyx Rapid Exchange Zotarolimus-Eluting Coronary Stent System, Resoulute Onyx Over The Wire Zotarolimus-Eluting

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 22C3 PHARMDX

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·VITRAX SODIUM HYALURONATE

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·META DDDR PACING SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·AKREOS POSTERIOR CHAMBERS INTRAOCULAR LENS

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity, Assurity+, Endurity, Endurity Core, Zenus, Zenex Family of Pacemakers

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·TEMPO PULSE GENERATORS

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·HANCOCK II PORCINE BIOPROSTHESIS