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

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·SCS EXTENSIONS, HINGED 2X4 SURGICAL LEAD, SPECIFY LEAD

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Guardant360 CDx

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·RESTORE FAMILY/ITREL3 FAMILY/SYNERGY FAMILY OF IMPLANTABLE NEUROSTIMULATORS/SPECIFY SURGICAL LEADS/HINGED 2X4 SURGICAL

    Implantable Cardioverter Defibrillator (Non-Crt)

    FDA Pre-Market Approval
    FDA Class 3 ·TELIGEN, PROGENY ICD AND NG ICD MODELS

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

    FDA Pre-Market Approval
    FDA Class 3 ·COGNIS, PROGENY CRT-D AND NG CRT-D MODELS

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT AFP-EIA

    Prosthesis, Knee, Hinged (Metal-Metal)

    FDA classification
    FDA Class 3 ·Prosthesis, Knee, Hinged (Metal-Metal)

    Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE