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

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·Nucleus 24 Cochlear Implant System

    VISITHERM

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    Catheter, Coronary, Atherectomy

    FDA Pre-Market Approval
    FDA Class 3 ·DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    Stimulator, Functional Walking Neuromuscular, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·PARASTEP-I

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Roche cobas EGFR Mutation Test, Roche cobas® DNA Sample Preparation Kit, cobas® EGFR Mutation Test v2, Roche cobas® cfD

    Pump, Drug Administration, Closed Loop

    FDA Pre-Market Approval
    FDA Class 3 ·GENESA(R) SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·Amplia MRI CRT-D / Brava CRT-D / Claria & Compia MRI CRT-D / Protecta CR-d / Protecta XT CRT-D / Viva S CRT-D

    Stimulator, Bone Growth, Non-Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·PHYSIO-STIM BONE GROWTH STIMULATOR

    Excimer Laser System

    FDA Pre-Market Approval
    FDA Class 3 ·BAUSCH & LOMB TECHNOLAS T217Z ZYOPTIX LASER SYSTEM