BEUDAMED
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    A.B. DENTAL DEVICES Dental Implants System

    FDA 510(k)
    FDA Class 2 ·Dental

    Oticon

    FDA UDI
    Oticon A/S·05707131305794·FM REC, AMIGO R12G2 216-218 MHZ C090

    BI-METRIC HEAD/NECK HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304222878·

    FLASH PTA BALLOON DILATATION CATHETER 5MM X 19MM X 135CM; FLASH PTA BALLOON DILATATION CATHETER 6MM X 19MM X 135CM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VENTED VIAL ADAPTER TRANSFER DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HUMAPEN LUXURA HALF-DOSE PEN

    FDA Adverse Event
    Injury ·ELI LILLY AND COMPANY·Product code NSC·October 10, 2014

    IAB: 8 FR - 30 CC FOS

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·June 6, 2013

    PULSAR MAX II

    FDA Adverse Event
    Injury ·GUIDANT CLONMEL IRELAND·Product code NVZ·July 14, 2011

    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