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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA ALK (D5F3) CDX ASSAY

    Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA ALK (D5F3) CDx Assay

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel

    Immunohistochemistry Test, Dna Mismatch Repair (Mmr) Protein Assay

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA MMR RxDx Panel

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·LeukoStrat® CDx FL T3 Mutation Assay

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (ADULT)

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM (PEDIATRIC)

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·CALRION CII BIONIC EAR SYSTEM (ADULT)

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-L1 (SP263) CDx Assay

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

    Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

    FDA Pre-Market Approval
    FDA Class 3 ·VENTANA PD-L1 (SP263) Assay

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·HIRESOLUTION & CLARION CII BIONIC EAR SYSTEMS

    Implant, Cochlear

    FDA Pre-Market Approval
    FDA Class 3 ·CLARION CII BIONIC EAR SYSTEM HIFOCUS ELECTRODE

    Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    FDA Pre-Market Approval
    FDA Class 3 ·PRECISION NOVI SPINAL CORD STIMULATION(SCS) SYSTEM