BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BREATHE CPAP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    UNIVERSAL TOTAL WRIST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BERLIN CHEMIE BERLIFINE® 31G X 8MM INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·June 14, 2016

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR REDWOOD CITY·Product code MGB·November 12, 2008

    ASR ACETABULAR CUPS 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·August 31, 2011

    LIGASURE IMPACT

    FDA Adverse Event
    Injury ·COVIDIEN LLC (SHANGHAI)·Product code GEI·July 12, 2013

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomography (CT), Model uMI 550 Part Number: 88000657 88000057

    FDA Enforcement
    Class II ·Ongoing·Shanghai United Imaging Healthcare Co., Ltd.·April 19, 2023

    Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only

    FDA Enforcement
    Class II ·Ongoing·UIH Technologies LLC·October 29, 2025