BEUDAMED
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    ANESTHESIA EXTENSION TUBES

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707028086·WEB 1ST MOLAR BANDS n.UR 27

    HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ALPHA ORTHOPAEDICS AT2 SYSTEM

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

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·May 20, 2014

    PROMUS ELEMENT ¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 6, 2012

    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