BEUDAMED
    392 results · 30ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

    FDA Pre-Market Approval
    FDA Class 3 ·UroVysion Bladder Cancer Kit

    Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

    FDA Pre-Market Approval
    FDA Class 3 ·Urovysion Bladder Cancer Kit

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT REALTIME HBV

    Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

    FDA Pre-Market Approval
    FDA Class 3 ·UROVYSION BLADDER CANCER KIT

    System, Test, Her-2/Neu, Nucleic Acid Or Serum

    FDA Pre-Market Approval
    FDA Class 3 ·Path Vysion HER-2 DNA Probe Kit

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT REALTIME HBV ASSAY, CALIBRATOR KIT, CONTROL KIT; ABBOTT MSAMPLE PREPARATION SYSTEMDNA.

    Hepatitis Viral B Dna Detection

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT REALTIME HBV ASSAY

    Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)

    FDA Pre-Market Approval
    FDA Class 3 ·Vysis CLL FISH Probe Kit

    Immunohistochemistry Assay, Antibody, Melanoma-Associated Antigen A4

    FDA Pre-Market Approval
    FDA Class 3 ·MAGE-A4 IHC 1F9 pharmDx

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·IPRO2 CGM SYSTEM WITH ENLITE SENSOR