BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    DUMEX WET DRESSINGS

    FDA 510(k)
    FDA Unclassified ·Unknown

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690124771·Modular Stem 13mm x 125mm

    Sierra

    FDA UDI
    Seaspine Orthopedics Corporation·10889981094454·14mm Drill

    NEURO II-S

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMMULITE IGF Control Module, IMMULITE Gastrin Control Module

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 27, 2014

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code MUZ·December 7, 2010

    IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·February 8, 2013

    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