BEUDAMED
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    YSI MODEL 801

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Symmetry Stevens

    FDA UDI
    ASPEN SURGICAL PRODUCTS, INC.·00887482128176·Symmetry® Scissors, Stevens Tenotomy, Straight,...

    Shoreline™ ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981189228·Distraction Pin 12mm

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197536554·Balfour lateral blades, one pair 89mm d...

    Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024139558·

    Trabecular Metal®

    FDA UDI
    Zimmer, Inc.·00889024139541·

    QUANTIMETRIC PLUS C4 REAGENT KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    NUTRIENT MIXTURE F-10 -HAM, N 1387, W/L-GLUTAMINE

    FDA 510(k)
    FDA Class 1 ·Hematology

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA·Product code NVN·June 10, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 6, 2010

    SECURA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·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