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

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    NAVIOS FLOW CYTOMETER SYSTEM

    FDA 510(k)
    FDA Class 2 ·Hematology

    ArgenZ HT+ 98x20 ML A4B

    FDA UDI
    ARGEN CORPORATION, THE·D818130373·Dental porcelain/ceramic restoration kit

    ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TYCHE PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    POWERPACK

    FDA Adverse Event
    Malfunction ·ICC-NEXERGY·Product code IYN·September 3, 2013

    ALLOCLASSIC VARIALL, SLV STEM, UNCEMENTED, 2, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·March 29, 2018

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·May 24, 2013

    EMAX 2 PLUS MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·September 30, 2014

    FREESTYLE NAVIGATOR

    FDA Adverse Event
    Malfunction ·Product code LFR·June 16, 2011

    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