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

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    BARD URODYNAMIC CATHETER

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

    AUTOSOFT 90

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·July 27, 2024

    BONE DRILLS OR TAPS

    FDA 510(k)
    FDA Class 2 ·Dental

    CIBA CORNING ACS PROLACTIN IMMUNOASSAY

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    HEARTSTART XL+DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 25, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

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

    WIDE-SPACED QUATTRODE PERCUTANEOUS LEAD

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION DIVISION·Product code GZB·December 9, 2010

    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