BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    MARTIN-LEWIS AGAR

    FDA 510(k)
    FDA Class 2 ·Microbiology

    HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    PTS PANELS CHOL+GLU TEST PANEL

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·May 30, 2014

    GYNNIE OB-GYN STRETCHER

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·October 24, 2012

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·September 22, 2010

    2.4MM STARDRIVE SCREWDRIVER SHAFT

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code HXX·January 18, 2017

    2.4MM STARDRIVE SCREWDRIVER SHAFT

    FDA Adverse Event
    Malfunction ·SYNTHES HAGENDORF·Product code HXX·January 18, 2017

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022