BEUDAMED
    2,435 results · 56ms · Sources: EU EUDAMED, US FDA

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·THxID-BRAF kit

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·OPEN PIVOT HEART VALVE, OPEN PIVOT AORTIC VALVED GRAFT, OPEN PIVOT HEART VALVE-APEX, OPEN PIVOT HEART VALVE-AP360

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AORTIC PROSTHESIS (ONXAAP)

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·COBAS 4800 BRAF V600 MUTATION TEST

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·On-X Prosthetic Heart Valve

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·OPEN PIVOT HEART VALVE

    Somatic Gene Mutation Detection System

    FDA Pre-Market Approval
    FDA Class 3 ·cobas BRAF V600 Mutation Test

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

    Somatic Gene Mutation Detection System

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

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·HALL (TM) EASY-FIT PROSTHETIC HEART VALVE

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE

    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 ·therascreen PIK3CA RGQ PCR Kit

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·CARBO-SEAL AND CARBO-SEAL VALSALVA ASCENDING AORTIC PROSTHESES

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·ATS MEDICAL OPEN PIVOT BI-LEAFLET MECHANICAL HEART VALVE

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)

    Somatic Gene Mutation Detection System

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

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·CARBOMEDICS(R) PROSTHETIC HEART VALVE/CARBO-SEAL(R) ASCENDING AORTIC PROSTHESIS

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·On-X Prosthetic Heart Valve, Model Onxa

    Heart-Valve, Mechanical

    FDA Pre-Market Approval
    FDA Class 3 ·ON-X PROSTHETIC HEART VALVE