BEUDAMED
    10,000 results · 36ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·StarClose SE® Vascular Surgical System

    Transcervical Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·ESSURE SYSTEM

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·BRIO FAMILY DEEP BRAIN STIMULATION (DBS) SYSTEMS

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·TAXUS LIBERTE LONG PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·EON MINI IPG NEUROSTIMULATION SYSTEM

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES HEART VALVES

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE Prime/Xpedition/Alpine/Sierra Everolimus Eluting Coronary Stent System (SV, LL)

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·AngioJet Rheolytic Thrombectomy System

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

    FDA Pre-Market Approval
    FDA Class 3 ·PROTECTA XT/PROTECTA/CONSULTA/MAXIMO II CRT-D DF4

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·ARCHITECT FREE PSA

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS.

    System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Fluency Plus Endovascular Stent Graft

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC ATTAIN STARFIX MODEL 4195 LEAD

    Aid, Surgical, Viscoelastic

    FDA Pre-Market Approval
    FDA Class 3 ·STAARVISC II & SHELLGEL SODIUM HYALURONATE

    Processor, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·MONOPREP PAP TEST

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

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM HBSAG/CONFIRMATORY

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·NIRXCELL COCR CORONARYSTENT ON RX SYSTEM

    System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

    FDA Pre-Market Approval
    FDA Class 3 ·PROLIEVE THERMODILATATION SYSTEM

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartMate 3™ Left Ventricular Assist System (LVAS)