BEUDAMED
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    IRRI-FLO IRRIGATION DELIVERY SYSTEM

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

    N.A.

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011891339000·1 caseTopic Roth 22 Brackets / For further info...

    Zavation eZspand Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PFC*SIGMA/OV/DOME PAT 3PEG,41

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JWH·January 31, 2018

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 31, 2014

    TOTALCARE BARIATRIC

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·November 2, 2010

    THROMBUSTER II

    FDA Adverse Event
    Malfunction ·KANEKA CORP.·Product code DXE·December 21, 2012

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012