BEUDAMED
    782 results · 19ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·Novoste™ Beta-Cath™ System

    Ventricular (Assist) Bypass

    FDA Pre-Market Approval
    FDA Class 3 ·HeartWare Ventricular Assist System

    Kit, Dna Detection, Human Papillomavirus

    FDA Pre-Market Approval
    FDA Class 3 ·cobas HPV Mg/Mn

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·mySCS™ GO Therapy Controller App

    Device, Hemostasis, Vascular

    FDA Pre-Market Approval
    FDA Class 3 ·Vascade Vascular Closure System (VCS)

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·therascreen BRAF V600E RGQ PCR Kit

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Shield

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

    FDA Pre-Market Approval
    FDA Class 3 ·Agilent Resolution ctDx FIRST

    Immunohistochemistry Assay, Antibody, Folr1

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

    Somatic Gene Mutation Detection System

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·MI Cancer Seek

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Abbott RealTime IDH1

    Immunohistochemistry Assay, Antibody, Folr1

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

    Somatic Gene Mutation Detection System

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

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

    FDA Pre-Market Approval
    FDA Class 3 ·MI Cancer Seek

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Shield

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Shield

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Shield

    System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

    FDA Pre-Market Approval
    FDA Class 3 ·Shield

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

    FDA Pre-Market Approval
    FDA Class 3 ·oncoRevealTM CDx