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

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    Xpert Xpress Strep A

    FDA 510(k)
    FDA Class 2 ·Microbiology

    MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NEXUS TKO-6, LUER-ACTIVATED DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DISCOVERY RF180

    FDA Adverse Event
    Injury ·GENERAL MEDICAL MERATE S.P.A.·Product code JAA·August 2, 2023

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 15, 2014

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 17, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 23, 2011

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016