BEUDAMED
    66 results · 17ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·Promote/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY,UNIFY ASSURA, UNIFY QUADRA

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart System

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart Mini System

    Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

    FDA Pre-Market Approval
    FDA Class 3 ·AAV5 DetectCDx®

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER® Smart System

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER® Smart System

    Assays To Detect Pre-Existing Antibodies To Adeno-Associated Virus (Aav) Viral Vectors

    FDA Pre-Market Approval
    FDA Class 3 ·AAV5 DetectCDx

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart Mini System

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart Mini IPG

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Optimizer Smart System and Optimizer Smart Mini System

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIhome Remote Patient Monitoring System

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart IPG

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·Optimizer Smart System (IPG)

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart and Smart Mini

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart Mini (OSM) system

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart System

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·GUARDIO/VESTA Charger firmware

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart System

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER Smart System

    Implantable Pulse Generator

    FDA Pre-Market Approval
    FDA Class 3 ·OPTIMIZER® Smart Mini