BEUDAMED
    8 results · 25ms · Sources: EU EUDAMED, US FDA

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    MULTICHEM S PLUS / S PLUS (ASSAYED)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MODIFICATION TO RENEW LEAD EXTENSION

    FDA 510(k)
    FDA Class 2 ·Neurology

    GMK-PRIMARY TIBIAL TRAY FIXED CEMENTED SIZE 5 RIGHT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 26, 2016

    ENDURANT

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·May 29, 2013

    STERLING BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·June 17, 2011

    JAGWIRE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code EZB·August 22, 2008

    Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.

    FDA Enforcement
    Class II ·Terminated·Ecolab Inc·September 30, 2015