BEUDAMED
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    CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER

    FDA 510(k)
    FDA Class 2 ·Hematology

    Blue Sky Bio Zygomatic Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    ITIMIZED INSTRUMENTS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BASEPLATE INSERTER ROD

    FDA Adverse Event
    Malfunction ·DEPUY IRELAND - 3015516266·Product code LXH·September 22, 2023

    M2A-MAGNUM PF CUP 54ODX48ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 24, 2014

    17MM REAMER W/STOP F/2.4MM VALINTERCARPAL FUSION PLATE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HRS·December 31, 2012

    POWER PRO AMBULANCE COT

    FDA Adverse Event
    Malfunction ·STRYKER CORP., MEDICAL DIV.·Product code INK·October 27, 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