BEUDAMED
    217 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QUANTIFERON-TB ANALYSIS SOFTWARE PROGRAM

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

    FDA Pre-Market Approval
    FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBS EIA & ANTI-HBS CALIBRATOR KIT

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

    FDA Pre-Market Approval
    FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIASORIN ETI MAK-2 PLUS ASSAY

    System, Test, Tumor Marker, For Detection Of Bladder Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ALERE NMP22 URINE COLLECTION KIT

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·ST AIA-PACK PA

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·IMMUNOASAY, PSA

    ZOLL M SERIES ETCO2 OPTION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ZOLL PAD WITH CPR AID

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ZOLL M SERIES

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ZOLL AED PLUS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ZOLL PAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    ZOLL M SERIES 12SL ANALYSIS OPTION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·AIA-PACK PSA

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·AIA-PACK PSA

    MAXIMA FILTERED HARDSHELL RESERVOIR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·Mentor MemoryGel Breast Implants

    Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

    FDA Pre-Market Approval
    FDA Class 3 ·Mentor MemoryShape Breast Implants

    Prosthesis, Breast, Inflatable, Internal, Saline

    FDA Pre-Market Approval
    FDA Class 3 ·Ideal Implant Saline-filled Breast Implant