BEUDAMED
    673 results · 28ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR

    Processor, Cervical Cytology Slide, Automated

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

    System, Non-Coherent Light, Photodynamic Therapy

    FDA Pre-Market Approval
    FDA Class 3 ·CURELIGHT BROADBAND (MODEL CURELIGHT 01)

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·EXPRESS/EXPRESS 2 MR & OTW CORONARY STENT SYSTEMS

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·NOVACOR LVAS

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·PRESTIGE CERVICAL DISC SYSTEM

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·TORONTO SPV VALVE

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

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

    Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

    FDA Pre-Market Approval
    FDA Class 3 ·MICRORUPTOR MR-2 ND:YAG LASER SYSTEM

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·CyPass Micro-Stent

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

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM, AUSAB

    Hepatitis Delta Serological Reagents

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ANTI-DELTA DIAGNOSTIC KIT (RIA)

    System, Laser, Photodynamic Therapy

    FDA Pre-Market Approval
    FDA Class 3 ·CERALAS I LASER

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·GIANTURCO-ROUBIN CORONARY FLEX-STENT(TM)

    System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

    FDA Pre-Market Approval
    FDA Class 3 ·ALERT SYSTEM (ALERT CATHETER, ALERT INTERFACE CABLE, AND ALERT COMPANION WITH SOFTWARE VERSION 1.08)

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·BioFreedom Drug Coated Coronary Stent System

    Laparoscopic Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·HULKA CLIP FOR TUBAL OCCLUSION