BEUDAMED
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    PLEUR-EVAC(R) A-8000--ADULT/PEDIATRIC CHEST DRAIN

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Route 92 Medical Delivery Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DEXIS SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    TRULIANT TIB IMP PS INSERT SZ 3.5 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·July 20, 2023

    CLEARCUT KNIVES

    FDA Adverse Event
    Malfunction ·ALCON RESEARCH, LTD. - ALCON PRECISION DEVICE·Product code HNN·July 6, 2015

    ITREL 3

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·June 24, 2014

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·November 4, 2010

    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