BEUDAMED
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    ORTHO VISION ID-MTS ANALYZER

    FDA Adverse Event
    Malfunction ·ORTHO CLINICAL DIAGNOSTICS·Product code KSZ·January 20, 2022

    COAGUCHEK ® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·September 11, 2018

    ORTHO VISION

    FDA Adverse Event
    Malfunction ·Product code KSZ·July 15, 2019

    Brain Stimulation Programming Planning Software.

    FDA classification
    FDA Class 2 ·Brain Stimulation Programming Planning Software.

    ACCU-CHEK ® INFORM II TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 26, 2020

    ACCU-CHEK ® INFORM II TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·March 26, 2020

    AQC

    FDA UDI
    Fertility Solutions, Inc.·08600105181752·Antisperm Antibody Quality Control for semen an...

    AQC

    FDA UDI
    Fertility Solutions, Inc.·00860010518144·Sperm Morphology Quality Control - Stained 2 ...

    AQC

    FDA UDI
    Fertility Solutions, Inc.·00860010518151·Sperm Morphology Quality Control - Unstained. 2...

    AQC

    FDA UDI
    Fertility Solutions, Inc.·00860010518175·Antisperm Antibody Quality Control for semen an...

    AQC

    FDA UDI
    Fertility Solutions, Inc.·00860010518182·Sperm Morphology Virtumorph® Quality Control - ...

    AQC

    FDA UDI
    Fertility Solutions, Inc.·00860010518168·Sperm Viability Quality Control. 2 stained and ...

    COBAS B 121

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CHL·July 16, 2014

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·October 11, 2012

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·October 11, 2012

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·October 11, 2012

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code LEG·October 11, 2012

    Q.C. TESTER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP

    FDA 510(k)
    FDA Class 2 ·Hematology

    Actalyke QC Kit - AQC-HP

    FDA UDI
    HELENA LABORATORIES CORPORATION·M525AQCHP0·