BEUDAMED
    3,128 results · 38ms · Sources: EU EUDAMED, US FDA

    PPD MEDITECH, DIV. OF INDUSTRIES PPD INC.

    FDA registration
    PPD MEDITECH, DIV. OF INDUSTRIES PPD INC.·1 product·🇨🇦 Canada

    Medical Absorbent Fiber

    FDA registration
    KOSMA-KARE CANADA INC.·1 product·🇨🇦 Canada

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·FoundationOne CDx (F1CDx)

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·therascreen PIK3CA RGQ PCR Kit

    Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HCV REAGENT PACK

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·therascreen FGFR RGQ PCR Kit

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·therascreen KRAS RGQ PCR Kit

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·therascreen EGFR RGQ PCR Kit

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Praxis Extended RAS Panel

    Fluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion

    FDA Pre-Market Approval
    FDA Class 3 ·TOP2A FISH PHARMDX KIT

    ST-302 INFRAREX

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SUNGLASSES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SD-956 ULTRASOUND THERAPY

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    IT-727 (ALSO KNOWN AS IT-610, IT-600 AND DYNAPHOR II

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SD-100 SKYEAR THERMOMETER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ONE STEP PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

    Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·MiSeqDx Extended RAS Panel

    Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

    FDA Pre-Market Approval
    FDA Class 2 ·COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0, COBAS AMPLICOR HCV TEST, VERSION 2.0

    Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

    FDA Pre-Market Approval
    FDA Class 3 ·QuantiFERON®-TB Gold Plus Test