BEUDAMED
    730 results · 22ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THXID™-BRAF

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Surpass Streamline Flow Diverter System, Surpass Evolve Flow Diverter System

    Somatic Gene Mutation Detection System

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

    Somatic Gene Mutation Detection System

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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS EGFR MUTATION TEST

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Pipeline Flex Embolization Device

    Somatic Gene Mutation Detection System

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

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Surpass Elite Flow Diverter System

    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 ·cobas BRAF V600 Mutation Test

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Pipeline™ Vantage Embolization Device with Shield Technology™ (Pipeline™ Vantage)

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS EGFR MUTATION TEST

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·QIAGEN THERASCREEN EGFR RGQ PCR KIT

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THERASCREEN EGFR RGQ PCR KIT

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Pipeline Flex Embolization Device (PFED)

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas KRAS Mutation Test

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·ROCHE COBAS KRAS MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Roche cobas EGFR Mutation Test / Roche cobas DNA Sample Preparation Kit

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·ROCHE COBAS EGFR MUTATION TEST, ROCHE COBAS DNA SAMPLE PREPARATION KIT

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THERASCREEN KRAS RGQ PCR KIT