BEUDAMED
    185 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Implantable Pulse Generator, Pacemaker (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 2920 (PRM) SYSTEM ZOOM (VIGOR DR/SR PACEMAKER SYSTEM)

    Pacemaker/Icd/Crt Non-Implanted Components

    FDA Pre-Market Approval
    FDA Class 3 ·MODEL 3140 ZOOM WIRELESS TRANSMITTER AND MODEL 3120 ZOOM LATITUDE PROGRAMMER/RECORDER/MONITOR (PRM)

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·Programmer Recorder Monitor (PRM) for Implantable Pulse Generators, Model 3300 LATITUDE Programming System, Model 6395 I

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·HiResolution Bionic Ear System

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip™ NTR/XTR Clip Delivery System, MitraClip™ G4 Clip Delivery System

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip G4 Delivery System

    Neuromodulator For Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip and MitraClip NT Clip Delivery System

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·PASCAL Precision – Implant System (PASCAL Implant, 10mm), PASCAL Precision – Implant System (PASCAL Ace Implant, 5mm)

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System

    Neuromodulator For Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Maestro Rechargeable System

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip System (NT)

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

    Neuromodulator For Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·Maestro Rechargeable System

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip™ G4 Clip Delivery System; MitraClip™ NTR Clip Delivery System; MitraClip™ XTR Clip Delivery System

    Neuromodulator For Obesity

    FDA Pre-Market Approval
    FDA Class 3 ·MAESTRO RECHARGEABLE SYSTEM

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·MitraClip System (NTR and XTR)

    Mitral Valve Repair Devices

    FDA Pre-Market Approval
    FDA Class 3 ·PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS