BEUDAMED
    717 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·SCANLENS (SCAFILCON A CONTACT LENS)

    Glue, Surgical, Arteries

    FDA Pre-Market Approval
    FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOSTE/BETA-CATH SYSTEM

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·URYX URETHRAL BULKING AGENT

    Glue, Surgical, Arteries

    FDA Pre-Market Approval
    FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

    Glue, Surgical, Arteries

    FDA Pre-Market Approval
    FDA Class 3 ·BIOGLUE SURGICAL ADHESIVE

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CardioMEMS HF System

    System, Laser, Transmyocardial Revascularization

    FDA Pre-Market Approval
    FDA Class 3 ·CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM

    System, Laser, Transmyocardial Revascularization

    FDA Pre-Market Approval
    FDA Class 3 ·ECLIPSE TMR HOLMIUM LASER SYSTEM

    System, Hemodynamic, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CardioMEMS Hospital System

    AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    AVAULTA SUPPORT SYSTEM

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    Aortic Valve, Prosthesis, Percutaneously Delivered

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

    Aortic Valve, Prosthesis, Percutaneously Delivered

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

    System, Test, Tumor Marker, For Detection Of Bladder Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·NMP22 BLADDERCHEK TEST KIT

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC COREVALVE SYSTEM