BEUDAMED
    7 results · 27ms · Sources: EU EUDAMED, US FDA

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    OLYMPUS CREATININE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    URINARY DIVERSION EVACUATING CATHETER

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

    DB 3000 A-SCAN SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·January 22, 2013

    TPS HANDPIECE CORD

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code DZI·December 9, 2010

    INTEGRITY RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code MAF·July 10, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021