BEUDAMED
    985 results · 18ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Temporary Non-Roller Type Left Heart Support Blood Pump

    FDA Pre-Market Approval
    FDA Class 3 ·IMPELLA 2.5 SYSTEM

    Bronchial Thermoplasty System

    FDA Pre-Market Approval
    FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

    Artificial Heart

    FDA Pre-Market Approval
    FDA Class 3 ·SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000, 7000TFX

    Pump, Infusion, Implanted, Programmable

    FDA Pre-Market Approval
    FDA Class 3 ·PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

    Transcervical Contraceptive Tubal Occlusion Device

    FDA Pre-Market Approval
    FDA Class 3 ·Essure System for Permanent Birth Control (Model ESS305)

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

    Stent, Superficial Femoral Artery

    FDA Pre-Market Approval
    FDA Class 3 ·SUPERA PERIPHERAL STENT SYSTEM (SUPERB)

    Device, Incontinence, Mechanical/Hydraulic

    FDA Pre-Market Approval
    FDA Class 3 ·PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL

    Permanent Defibrillator Electrodes

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC ATTAIN STARFIX MODEL 4195 LEAD

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·SIENTRA SILICONE GEL BREAST IMPLANTS

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·MEMORYGEL BREAST IMPLANT

    Implant, Dermal, For Aesthetic Use

    FDA Pre-Market Approval
    FDA Class 3 ·SCULPTRA

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOCURE NOVOTTF-100A SYSTEM

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·OPEN PIVOT BI-LEAFLET HEART VALVE

    Stent, Carotid

    FDA Pre-Market Approval
    FDA Class 3 ·XACT CAROTID STENT SYSTEM

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·TALENT THORACIC STENT GRAFT SYSTEM

    Barrier, Adhesion, Cardiovascular

    FDA Pre-Market Approval
    FDA Class 3 ·REPEL-CV

    Diagnostic Low Electric Field

    FDA Pre-Market Approval
    FDA Class 3 ·MARGINPROBE SYSTEM