BEUDAMED
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    CYPRESS MEDICAL PRODUCTS CATHETER (INSERTION) TRAY

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

    STEINMANN PIN/TROCAR POINT

    FDA UDI
    Biomet Orthopedics, LLC·00880304416581·

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124757·Modular Stem 9mm x 125mm

    R605 FACS COLLIMETER

    FDA 510(k)
    FDA Class 2 ·Radiology

    STERISPINE PS Pedicle Screw

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOLDING SLEEVE WITH LOCKING

    FDA Adverse Event
    Injury ·SYNTHES MONUMENT·Product code HXX·February 6, 2013

    CYCLER DRAINAGE SET - MULTILINGUAL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·January 6, 2011

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·July 22, 2014

    IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·August 20, 2014