BEUDAMED
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    SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    PageWriter

    FDA UDI
    Philips Medical Systems Hsg·00884838032514·PageWriter TC70 US Government all-inclusive bun...

    HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MAGEC® Spinal Bracing and Distraction System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPSURE SP NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    TOTALCARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·November 5, 2012

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    FDA Adverse Event
    Malfunction ·IRIDEX·Product code HQF·September 17, 2010

    PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evaluate the electrocardiogram of adult and pediatric patients

    FDA Recall
    Open, Classified ·Philips North America, LLC·Product code DPS·January 9, 2019

    PageWriter TC70 w/trolley Government Bundle, Product 860352, Software revisions up to and including A.07.05. 22 to evaluate the electrocardiogram of adult and pediatric patients

    FDA Enforcement
    Class II ·Ongoing·Philips North America, LLC·February 27, 2019

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012