BEUDAMED
    104 results · 17ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION RXL MAX TPSA FLEX REAGENT CARTRIDGE

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·MAMMOMAT Revelation with Tomosynthesis Option System

    Lenses, Soft Contact, Extended Wear

    FDA Pre-Market Approval
    FDA Class 3 ·V-X (POLYMACON) ASPHERIC SOFT(HYDROPHILIC) LENSES

    Artificial Iris

    FDA Pre-Market Approval
    FDA Class 3 ·CustomFlex Artificial Iris

    Artificial Iris

    FDA Pre-Market Approval
    FDA Class 3 ·CustomFlex ArtificialIris

    Artificial Iris

    FDA Pre-Market Approval
    FDA Class 3 ·CustomFlex Artificial Iris

    Artificial Iris

    FDA Pre-Market Approval
    FDA Class 3 ·CustomFlex Artificial Iris

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·SENOCLAIRE

    Digital Breast Tomosynthesis

    FDA Pre-Market Approval
    FDA Class 3 ·SENOGRAPHE PRISTINA 3D

    Stimulator, Low Electric Field, Tumor Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT

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

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION FPSA FLEX REAGENT CARTRIDGE

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

    FDA Pre-Market Approval
    FDA Class 3 ·Dimension Vista FPSA Flex reagent cartridge (K6452)