BEUDAMED
    2,153 results · 20ms · Sources: EU EUDAMED, US FDA
    Filters Classification: FDA Class 3 ×

    Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

    FDA Pre-Market Approval
    FDA Class 3 ·Elecsys Anti-HBs II, PreciControl Anti-HBs

    Somatic Gene Mutation Detection System

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

    Somatic Gene Mutation Detection System

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

    Somatic Gene Mutation Detection System

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

    Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

    FDA Pre-Market Approval
    FDA Class 3 ·DIMENSION TPSA FLEX REAGENT CARTRIDGE

    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 ·cobas EGFR Mutation Test and cobas EGFR Mutation Test v2

    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 ·COBAS EGFR MUTATION TEST

    MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LIFEPAK 12 BIPHASIC

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LIFEPAK 20 DEFIBRILLATOR/ MONITOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODIFIED OSCOR PY PACING LEADS/MODIFICATION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LAERDAL

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LIFEPAK 12, 20, 500, CR PLUS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HEWLETT PACKARD DEFIBRILLATORS

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION

    FDA 510(k)
    FDA Class 3 ·Cardiovascular