BEUDAMED
    7 results · 16ms · Sources: EU EUDAMED, US FDA

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    THERAPAX 150A

    FDA 510(k)
    FDA Class 2 ·Radiology

    PENTAX Video Colonoscopes (EC Family)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    COLORISE RIGID

    FDA 510(k)
    FDA Class 2 ·Dental

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 30, 2014

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 10, 2012

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·May 15, 2015

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020