BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    FDA 510(k)
    FDA Class 2 ·Radiology

    ABX PENTRA MICRO ALB CONTROL L/H

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PALINDROME 14.5 FR CHRONIC HEMODIALYSIS CATHETER

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

    RAD-G

    FDA Adverse Event
    Malfunction ·MASIMO - 15750 ALTON PKWY·Product code DQA·October 17, 2024

    COLLEAGUE

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

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 6, 2014

    GYNECARE TVT SECUR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code PAH·July 18, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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