BEUDAMED
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    Orthodontic Acrylic 2

    FDA 510(k)
    FDA Class 2 ·Dental

    BIO-CLAD ALL POLY CUP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304255999·

    3M™ Unitek™

    FDA UDI
    3M UNITEK CORPORATION·00652221046659·Unitek(TM) Molar Band General Purpose Wide Hard...

    JOURNEY II DEEP DISHED ARTICULAR INSERTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CROSSPLAN / ACCUSOFT-XL V.4.04

    FDA 510(k)
    FDA Class 2 ·Radiology

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·July 28, 2017

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·July 28, 2017

    NIM CONTACT® STANDARD EMG REINFORCED ENDOTRACHEAL TUBE

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code ETN·October 10, 2014

    MINSTREL

    FDA Adverse Event
    Other ·MEDIBO MEDICAL PRODUCTS NV·Product code FSA·July 4, 2011

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    UNKNOWN·Product code IKX·June 11, 2013

    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