BEUDAMED
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    GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GC Initial™

    FDA UDI
    Gc America Inc.·J0228700741·GC Initial™ MC Translucent Modifier TM-01, 20g

    GC Initial™

    FDA UDI
    Gc America Inc.·15400556703271·GC Initial™ MC Translucent Modifier TM-01, 20g

    nvc

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LUBRINA, MODEL HIM-1

    FDA 510(k)
    FDA Class 1 ·Dental

    KNIFE

    FDA Adverse Event
    Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·April 29, 2014

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·October 15, 2010

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·December 12, 2012

    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