BEUDAMED
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    MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA

    FDA 510(k)
    FDA Class 2 ·Microbiology

    "2.4MM" SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036053529·

    POLY-CHEM 90 ISE MODULE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Custodiol HTK Solution

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

    RADIFOCUS INTRODUCER

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·May 28, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 12, 2013

    BV PULSERA

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code IZL·November 15, 2010

    Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·November 30, 2016

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012