BEUDAMED
    95 results · 28ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    FIRST MEDIC MODE 610

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    HEARTSTART 2000

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Replacement Heart-Valve

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

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 DR, ALTRUA 2 SR

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 SR, ALTRUA 2 DR

    Stimulator, Carotid Sinus Nerve

    FDA Pre-Market Approval
    FDA Class 3 ·BAROSTIM NEO® System

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·CareLink SmartSync™ Micra VR App, CareLink SmartSync™ Micra AV App

    Stimulator, Carotid Sinus Nerve

    FDA Pre-Market Approval
    FDA Class 3 ·Barostim™ System Heart Failure

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·LATITUDE NXT PATIENT MANAGEMENT SYSTEM

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·PSW 2202.U and NEO 2202.U

    Stimulator, Carotid Sinus Nerve

    FDA Pre-Market Approval
    FDA Class 3 ·Barostim™ System

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·LATITUDE CONSULT SYSTEM

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE

    Stimulator, Carotid Sinus Nerve

    FDA Pre-Market Approval
    FDA Class 3 ·Barostim NEO System, Barostim NEO2 System

    Stimulator, Carotid Sinus Nerve

    FDA Pre-Market Approval
    FDA Class 3 ·BAROSTIM NEO® System

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·Renamic Neo Programmer

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC CARELINK MONITOR, MYCARELINK PATIENT MONITOR

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·REVEAL DX, REVEAL XT

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·MEDTRONIC MODELS 2490C CARELINK REMOTE HOME MONITORS

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION