BEUDAMED
    560 results · 37ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Kit, Assay, Estrogen Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·ER-EIA MONOCLONAL

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

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

    Kit, Assay, Progesterone Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·PGR-EIA MONOCLONAL

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

    FDA Pre-Market Approval
    FDA Class 3 ·MONOLISA ANTI-HBS EIA

    Kit, Assay, Progesterone Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT PGR-EIA MONOCLONAL

    Hepatitis Delta Serological Reagents

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT ANTI-DELTA EIA

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

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT HBE (RDNA) EIA

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Powerheart® G5 AED

    Automated External Defibrillators (Non-Wearable)

    FDA Pre-Market Approval
    FDA Class 3 ·Powerheart® G5 AED

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

    FDA Pre-Market Approval
    FDA Class 3 ·MONOLISA ANTI-HBC EIA

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

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT HBE (RDNA) EIA

    Kit, Assay, Progesterone Receptor

    FDA Pre-Market Approval
    FDA Class 3 ·ABBOTT PGR-EIA MONOCLONAL

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

    FDA Pre-Market Approval
    FDA Class 3 ·MONOLISA ANTI-HBS EIA

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

    FDA Pre-Market Approval
    FDA Class 3 ·BIO-RAD MONOLISA ANTI-HBC EIA

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

    FDA Pre-Market Approval
    FDA Class 3 ·MONOLISA ANTI-HBC IGM EIA

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

    FDA Pre-Market Approval
    FDA Class 3 ·MONOLISA ANTI-HBC IGM EIA

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

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

    Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

    FDA Pre-Market Approval
    FDA Class 3 ·BIOTRIN PARVOVIRUS IGM EIA (V619IMUS)

    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