BEUDAMED
    10,000 results · 27ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2800 & 2800TFX

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·POLYMETHYLMETHACRYLATE INTRAOCULAR LENSES

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·Medtronic MiniMed 630G Insulin Pump

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Hancock Valved Conduiis

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·Dexcom G5 Mobile Continuous Glucose Monitoring System

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·VASCADE VASCULAR CLOSURE SYSTEM (VCS)

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·Flash Glucose Monitoring System

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

    FDA Pre-Market Approval
    FDA Class 3 ·AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·Dexcom G5 Mobile Continuous Glucose Monitoring System

    Intraocular Lens

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

    Implantable Pacemaker Pulse-Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Assurity, Assurity+, Endurity

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed iPro2 CGM System with Enlite Sensor

    Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

    FDA Pre-Market Approval
    FDA Class 3 ·Quadra Allura MP RF CRT-P. Quadra Allure MP CRT-P, Allura Quadra CRT-P, Anthem RF CRT-P, Frontier II CRT-P Pacemakers

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·XIENCE Skypoint Everolimus Eluting Coronary Stent System

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra™ Transcatheter Heart Valve

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    Tester, Acoustic, Bone Quality

    FDA Pre-Market Approval
    FDA Class 3 ·QUS-2 CALCANEAL ULTRASONOMETER

    Ventricular (Assist) Bypass

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