BEUDAMED
    2,910 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·Atellica IM Hepatitis B core IgM (aHBcM) assay; Atellica IM Hepatitis B core lgM Quality Control (aHBcM QC)

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·Alinity i Anti-HBc lgM

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·LIAISON® XL MUREX HBc lgM assay and Control

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ELECSYS ANTI-HBC IGM TEST SYSTEM

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·ADVIA CENTAUR HBC IGM READYPACK REAGENTS, ADVIA CENTAUR HBC IGM QUALITY CONTROL MATERIALS

    ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER

    FDA 510(k)
    FDA Class 3 ·Unknown

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM CGM

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·IPRO2 CGM RECORDER

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·iPro2 CGM System

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·G5 Mobile Continuous Glucose Monitoring System

    Sensor, Glucose, Implanted, Non-Adjunctive Use

    FDA Pre-Market Approval
    FDA Class 3 ·Eversense E3 CGM System

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·SOF SENSOR

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    Sensor, Glucose, Invasive

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

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·iPro2 CGM System with Enlite Sensor

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·iPro2 CGM System with Enlite Sensor

    Sensor, Glucose, Invasive

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

    Sensor, Glucose, Invasive

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

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·iPro2 CGM System with Enlite Sensor

    Sensor, Glucose, Invasive

    FDA Pre-Market Approval
    FDA Class 3 ·iPro2 Continuous Glucose Monitoring (CGM) System