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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Abbott RealTime IDH2 Amplification Reagent Kit, Abbott RealTime IDH2 Control Kit

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED®) System, FREDX System

    Somatic Gene Mutation Detection System

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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Cobas EGFR Mutation Test v2, Cobas DNA and cfDNA Sample Preparation Kit

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED) and FRED X System

    Somatic Gene Mutation Detection System

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

    Somatic Gene Mutation Detection System

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

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·PIPELINE EMBOLIZATION DEVICE

    Somatic Gene Mutation Detection System

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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Abbott RealTime IDH2

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas® EZH2 Mutation Test

    Somatic Gene Mutation Detection System

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

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·Cobas EGFR Mutation Test and Cobas EGFR v2 Mutation Test

    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 ·RealTime IDH1

    Intracranial Aneurysm Flow Diverter

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

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Flow Re-Direction Endoluminal Device (FRED®) System

    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 ·LeukoStrat CDx FLT3 Mutation Assay

    Intracranial Aneurysm Flow Diverter

    FDA Pre-Market Approval
    FDA Class 3 ·Surpass Evolve™ Flow Diverter Stent System