BEUDAMED
    3,221 results · 119ms · Sources: EU EUDAMED, US FDA

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODEL 2650

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Pericardial Mitral Bioprosthesis, Model 11000M

    Aortic Valve, Prosthesis, Percutaneously Delivered

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

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX MITRAL LOW PRESSURE BIOPROSTHESIS

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·Edwards Commander Delivery System

    Pulmonary Valve Prosthesis Percutaneously Delivered

    FDA Pre-Market Approval
    SAPIEN 3 Transcatheter Heart Valve System

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS INTUITY ELITE Valve System

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis/Theon Pericardial Aortic Bioprosthesis with ThermaFix tiss

    Aortic Valve, Prosthesis, Percutaneously Delivered

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

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE PORCINE

    Aortic Valve, Prosthesis, Percutaneously Delivered

    FDA Pre-Market Approval
    FDA Class 3 ·SAPIEN XT TRANSCATHETER HEART VALVE

    Replacement Heart-Valve

    FDA Pre-Market Approval
    FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES

    Edwards Lifesciences B.V.

    Importer
    🇳🇱 Netherlands·1 Manufacturer

    Edwards Lifesciences GmbH

    Authorized representative
    🇩🇪 Germany·2 Manufacturers

    Edwards Lifesciences LLC

    System producer
    🇺🇸 United States

    HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Swang-Ganz IQ pulmonary artery catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable

    FDA 510(k)
    FDA Class 2 ·Cardiovascular