BEUDAMED
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    CR PERFECT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Sierra

    FDA UDI
    Seaspine Orthopedics Corporation·10889981094546·French Rod Bender

    RESMED MERIDIAN MASK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Single Use Balloon Dilator V (with Knife)

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

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 27, 2014

    RIATA ACTIVE FIXATION

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 8, 2013

    SAGITTAL BLADE 18.0X1.27X100MM

    FDA Adverse Event
    Malfunction ·STRYKER IRELAND LTD·Product code GFA·December 8, 2010

    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