BEUDAMED
    9 results · 21ms · Sources: EU EUDAMED, US FDA

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    NEW SECOND FRENCH SIZE MAHURKAR CATHETER

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

    Symmetry Kaye-Freeman

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482128237·Symmetry® Scissors, Kaye-Freeman Face Lift, Cur...

    CPK REAGENT SET (COLORIMETRIC)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SIEMENS SIRECUST MODELS 403P,403-2P & 403N

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2014

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 12, 2010

    SPRINT

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·December 10, 2012

    M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors

    FDA Enforcement
    Class II ·Terminated·Philips Electronics North America Corporation·June 21, 2017

    M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors

    FDA Recall
    Terminated ·Philips Electronics North America Corporation·Product code MHX·December 17, 2010