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

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    AC3™ Series IABP

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102497·MILDER PHACO SPATULA, LEFT

    ID NOW COVID-19 2.0 TEST KIT 24T JAPAN

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·October 19, 2023

    ID NOW COVID-19 2.0 TEST KIT 24T JAPAN

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·October 19, 2023

    MARIGEN WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )

    FDA 510(k)
    FDA Class 2 ·Microbiology

    T:SLIM X2 INSULIN PUMP

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·May 3, 2019

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·November 13, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011

    U BY KOTEX CLICK

    FDA Adverse Event
    Malfunction ·AVENT SA DE R.L. DE C.V.·Product code HEB·December 11, 2012

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025