BEUDAMED
    10,000 results · 34ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Ventricular (Assist) Bypass

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

    Ventricular (Assist) Bypass

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

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Mosaic Bioprosthesis

    Implant, Intragastric For Morbid Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·LAP-BAND Adjustable Gastric Banding System

    Coronary Drug-Eluting Stent

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

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MiniMed 630G System with SmartGuard

    Valve, Pulmonary

    FDA Pre-Market Approval
    FDA Class 3 ·Zephyr Endobronchial Valve (EBV) System

    Device, Hemostasis, Vascular

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

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·MULTI-LINK OTW ZETA CORONARY STENT SYSTEMS

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER

    Aortic Valve, Prosthesis, Percutaneously Delivered

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

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·DEFLUX

    Pulse-Generator, Single Chamber, Sensor Driven, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·Microny

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·XACT™ Carotid Stent System

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biofinity Sphere (comfilcon A)

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·Sensar 1-piece IOL, Tecnis 1-piece IOL, Tecnis 1-piece Optiblue IOL, Preloaded Tecnis 1-piece IOL, Preloaded Tecnis 1-pi

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

    FDA Pre-Market Approval
    FDA Class 3 ·QUICKFLEX FAMILY OF LEADS

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Aptima HBV Quant Assay

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·Biomedics Toric/ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses

    Drug-Coated Peripheral Transluminal Angioplasty Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter