BEUDAMED
    10,000 results · 23ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·CGMS IPRO CONTINUOUS GLOCOSE MONITORING SYSTEM

    Intraocular Lens

    FDA Pre-Market Approval
    FDA Class 3 ·CT LUCIA Intraocular Lens (IOL)

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS(R) BIOPROSTHESIS, MODELS 2625 AND 6625

    Ventricular (Assist) Bypass

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

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 3038 FUNCTION PACT FOR ASP-II 3003 PROGRAMME

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·PARADIGM REAL-TIME REVEL SYSTEM

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS HBV TEST

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·ZETA RX/ULTRA RX/OTW

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER- EDWARDS PORCINE BIOPROSTHESIS

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER EDWARDS BIOPROSTHESIS

    Automated Insulin Dosing , Threshold Suspend

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

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·Valiant Thoracic Stent Graft With the Captivia Delivery System

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ANEURX AAADVANTAGE STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·MULTI-LINK 8 CORONARY STENT SYSTEM

    Sealant, Polymerizing

    FDA Pre-Market Approval
    FDA Class 3 ·Tridyne Vascular Sealant

    Cardiac Ablation Percutaneous Catheter

    FDA Pre-Market Approval
    FDA Class 3 ·Chilli II ™ Cooled Ablation Catheter and Cable

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Hancock II Bioprosthesis

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis (RESILIA tissue)