BEUDAMED
    105 results · 38ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·THORATEC HEARTMATE II LVAS

    Pulse Generator, Permanent, Implantable

    FDA Pre-Market Approval
    FDA Class 3 ·CareLink SmartSync Base, Patient Connector, Host App, PSA App, Common App, and CareLink SmartSync Platform App

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·HFX App

    Leadless Pacemaker

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

    Pacemaker/Icd/Crt Non-Implanted Components

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

    Dorsal Root Ganglion Stimulator For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·NeuroSphere Digital Health Apps

    Reader, Cervical Cytology Slide, Automated

    FDA Pre-Market Approval
    FDA Class 3 ·BD FOCALPOINT SLIDE PROFILER

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·INFINITY NEUROSTIMULATION SYSTEM

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·INFINITY NEUROSTIMULATION SYSTEM

    S.A.F. ACETABULAR CUP

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    S.A.F. ACETABULAR CUP WITH POROUS COATING

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    SAMUELSON ACETABULAR CUP

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    SAMUELSON SCREWLOC CUP

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    CLX ACETABULAR CUP (WAGNER) FOR CEMENTLESS FIXAT.

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    SCHUSTER ACETABULAR CUP FOR CEMENT/CEMENTLESS FIX.

    FDA 510(k)
    FDA Class 3 ·Orthopedic

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    FDA Pre-Market Approval
    FDA Class 3 ·Clinician Programmer Application Version 2.0.2, and Liberta RC DBS IPG Firmware Version 1.1.1

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·Patient Controller Application Version 2.0.2

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

    FDA Pre-Market Approval
    FDA Class 3 ·CareLink SmartSync Cobalt, Crome App

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·mySCS™ GO Therapy Controller App