BEUDAMED
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    AFF (MARK I) VOLUMETRIC INFUSION PUMP

    FDA 510(k)
    FDA Class 2 ·General Hospital

    LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONSERVE(R) TOTAL A-CLASS HEAD

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code JDL·April 22, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code MDS·March 29, 2011

    STRATUS CS STAT FLUOROMETRIC ANALYZER

    FDA Adverse Event
    Malfunction ·DADE BEHRING, INC.·Product code JJE·July 2, 2008

    KYPHON KURVE BONE FILLER DEVICE 13GA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEXICO·Product code KIH·July 14, 2020

    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The system is indicated for long bone fracture fixation, specifically tibial fracture fixation. The sleeves are intended to ease nail insertion and to protect the condyle surfaces during nail insertion.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·October 22, 2014