BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    ASEPTECH PORTABLE RO+ SYSTEM

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

    GDC-1501

    FDA 510(k)
    FDA Class 2 ·Dental

    GLOBAL TOTAL SHOULDER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENDO GIA ROTICULATOR* 30-3.5 SULU

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY US SUR·Product code GDW·June 25, 2014

    MICRO OSCILLATING SAW

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

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

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

    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