BEUDAMED
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    RELIEF VALVE-HONAN INTRAOC. PRESSURE

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707028079·WEB 1ST MOLAR BANDS n.UR 26

    MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR

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

    YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 2, 2012

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 20, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code MDS·August 30, 2010

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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