BEUDAMED
    10,000 results · 36ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Prosthesis, Intervertebral Disc

    FDA Pre-Market Approval
    FDA Class 3 ·Simplify® Cervical Artificial Disc

    Sensor, Glucose, Invasive

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

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ANEURX STENT GRAFT SYSTEM

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·MOSIAC PORCINE BIOPROSTHESIS, MODELS 305, 310

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·MOSAIC PORCINE BIOPROSTHETIC

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Sapien XT Transcatheter Heart Valve

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

    FDA Pre-Market Approval
    FDA Class 3 ·CD3231-40, CD3231-40Q, CD3257-40, CD3257-40Q, CD3357-40, CD3357-40C, CD3357-40Q, CD3357-40QC,

    Ventricular (Assist) Bypass

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

    Coronary Drug-Eluting Stent

    FDA Pre-Market Approval
    FDA Class 3 ·ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·VISION RX/OTW/MINI VISION RX/OTW/MULTI LINK 8 OTW

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·SOFPORT/SOFLEX INTRAOCULAR LENSES

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

    Automated Insulin Dosing , Threshold Suspend

    FDA Pre-Market Approval
    FDA Class 3 ·MINIMED 530G INSULIN PUMP

    Sealant, Polymerizing

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

    Intraocular Pressure Lowering Implant

    FDA Pre-Market Approval
    FDA Class 3 ·GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·FLUOROPERM RGP CONTACT LENSES

    Agent, Bulking, Injectable For Gastro-Urology Use

    FDA Pre-Market Approval
    FDA Class 3 ·DEFLUX Injectable Gel

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

    FDA Pre-Market Approval
    FDA Class 3 ·EPIC HF/ATLAS + HF FAMILY

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards INSPIRIS RESILIA Aortic Valve and Edwards Pericardial Aortic Bioprosthesis

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Durata and Optisure High Voltage Leads