BEUDAMED
    10,000 results · 26ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·NIRXCELL COCR CORONARY STENT ON RX

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·OVATIO VR/DR

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·enVista® Hydrophobic Acrylic Intraocular Lens (IOL)

    Lenses, Soft Contact, Extended Wear

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

    Lens, Multifocal Intraocular

    FDA Pre-Market Approval
    FDA Class 3 ·TECNIS® 3-Piece Multifocal

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·Misago RX Self-expanding Peripheral Stent

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·PREVELLE SILK

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·RX ACCULINK AND ACCULINK CAROTID STENT SYSTEMS

    Defibrillator, Implantable, Dual-Chamber

    FDA Pre-Market Approval
    FDA Class 3 ·TUPOS LV/ATX, KRONOS LV-T, LUMAX 300/340 FAMILY OF ICDS AND CRT-DS

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC MODEL 5388 EXTERNAL PULSE GENERATOR

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·TRIFECTA VALVE

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·Dexcom G4 PLATINUM Continuous Glucose Monitoring System; Dexcom G5 Mobile Continuous Glucose Monitoring System

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

    FDA Pre-Market Approval
    FDA Class 3 ·COROX OTW (-S) BP STEROID-ELUTING LEADS

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·CHILLI COOLED RF ABLATION SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·IMMULITE ANTI-HEPATITIS B SURFACE ANTIGEN (ANTI-HBS) SYSTEMS

    Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

    FDA Pre-Market Approval
    FDA Class 3 ·INSYNC/INSYNC III CRT-PS

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·Astron Pulsar/Pulsar-18 Stent System

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Obalon Balloon System

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·MECHANICAL HEART VALVES

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·AXSYM AFP (LN 7A48)