BEUDAMED
    51 results · 15ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

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

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

    Immunohistochemistry Assay, Antibody, Folr1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

    Immunohistochemistry Assay, Antibody, Folr1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

    Immunohistochemistry Assay, Antibody, Folr1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

    Immunohistochemistry Assay, Antibody, Folr1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume™ BPH Catheter System

    Immunohistochemistry Assay, Antibody, Folr1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

    Immunohistochemistry Assay, Antibody, Folr1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA FOLR1 (FOLR-2.1) RxDx Assay

    Immunohistochemistry Assay, Antibody, Folr1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume™ BPH Catheter System

    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia

    FDA Pre-Market Approval
    FDA Class 3 ·Optilume™ BPH Catheter System

    Lipoprotein, Low Density, Removal

    FDA Pre-Market Approval
    FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·Access AFP Reagents on the Access Immunoassay Systems

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

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

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

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech PSA Reagents on the Access Immunoassay Systems

    P2psa

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

    Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

    FDA Pre-Market Approval
    FDA Class 3 ·Acess AFP Reagents on the Access Immunoassay Systems

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

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech PSA Reagents on the Access Immunoassay Systems

    P2psa

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

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

    FDA Pre-Market Approval
    FDA Class 3 ·Access Hybritech Free PSA Reagents on the Access Immunoassay Systems