BEUDAMED
    52 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 ·PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

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

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS HYBRITECH FREE PSA ON THE SYNCHRON LXI 725 SYSTEM

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS AFP ASSAY ON THE SYNCHRON LXI 725 SYSTEM

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

    Heart-Valve, Non-Allograft Tissue

    FDA Pre-Market Approval
    FDA Class 3 ·MITROFLOW AORTIC PERICARDIAL HEART VALVE MODEL LX

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE 2000 SYSTEM

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·InSightec ExAblate System

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE 2000, VERSION 4.22

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE 2000 SYSTEM

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE 2000/2100

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·Exablate 2100/2100V1 System

    Ultrasound, Hyperthermia, Cancer Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE 2000 SYSTEM

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE 2000

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE DEVICE

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE SYSTEM

    Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

    FDA Pre-Market Approval
    FDA Class 3 ·EXABLATE