BEUDAMED
    1,066 results · 20ms · Sources: EU EUDAMED, US FDA

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    IQM Integral Quality Monitor (also IQM)

    FDA 510(k)
    FDA Class 2 ·Radiology

    IL GEM 4000 ABG ANALYZER

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORIES·Product code CHL·December 21, 2012

    IQM Integral Quality Monitor

    FDA UDI
    iRT Systems GmbH·B50510130·IQM is quality assurance device for medical lin...

    IQ MS WIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQX·December 6, 2006

    GEM PREMIER 5000 PAK

    FDA Adverse Event
    Injury ·INSTRUMENTATION LABORATORY CO.·Product code CHL·September 29, 2025

    GEM 4000

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORIES·Product code CHL·February 13, 2019

    INTELISWAB COVID-19 RAPID TEST

    FDA Adverse Event
    Malfunction ·ORASURE TECHNOLOGIES INC.·Product code QKP·December 28, 2021

    GEM 4000 PREMIER CARTRIDGE

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code CHL·January 28, 2019

    GEM PREMIER CHEMSTAT PAK

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code JFY·June 6, 2025

    ESSURE

    FDA Adverse Event
    Injury ·BAYER·Product code HHS·June 29, 2015

    IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    GEM Premier 3000 iQM - BG HCT - 75 Tests

    FDA UDI
    INSTRUMENTATION LABORATORY COMPANY·08426950088189·GEM Premier 3000 iQM 4WK - BG HCT - 75 Tests

    GEM Premier 3000 iQM - BG HCT - 150 Tests

    FDA UDI
    INSTRUMENTATION LABORATORY COMPANY·08426950082361·GEM Premier 3000 iQM 3WK - BG HCT - 150 Tests

    GEM Premier 3000 iQM - BG HCT - 300 Tests

    FDA UDI
    INSTRUMENTATION LABORATORY COMPANY·08426950082392·GEM Premier 3000 iQM 3WK - BG HCT - 300 Tests

    GEM Premier 3500 iQM BG HCT (75 TEST)

    FDA UDI
    INSTRUMENTATION LABORATORY COMPANY·08426950511557·GEM Premier 3500 iQM 3WK BG HCT (75 TEST)

    GEM Premier 3000 iQM - BG HCT - 35 Tests

    FDA UDI
    INSTRUMENTATION LABORATORY COMPANY·08426950452430·GEM Premier 3000 iQM 4WK - BG HCT - 35 Tests

    GEM Premier 3000 iQM - BG HCT - 600 Tests

    FDA UDI
    INSTRUMENTATION LABORATORY COMPANY·08426950446217·GEM Premier 3000 iQM 2WK - BG HCT - 600 Tests

    GEM Premier 3000 iQM - BG HCT - 75 Tests

    FDA UDI
    INSTRUMENTATION LABORATORY COMPANY·08426950087960·GEM Premier 3000 iQM 3WK - BG HCT - 75 Tests

    GEM Premier 3000 iQM - BG HCT - 450 Tests

    FDA UDI
    INSTRUMENTATION LABORATORY COMPANY·08426950082422·GEM Premier 3000 iQM 3WK - BG HCT - 450 Tests

    GEM PREMIER CHEMSTAT PAK

    FDA Adverse Event
    Malfunction ·INSTRUMENTATION LABORATORY CO.·Product code JFY·December 18, 2025