BEUDAMED
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    COLLIMATOR F-20

    FDA 510(k)
    FDA Class 2 ·Radiology

    Instrument Case

    FDA UDI
    KATENA PRODUCTS, INC.·00841668110973·STERILIZING CASE MEDIUM/SMALL

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776202040·GRAYSON MANIPULATOR

    MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    HPR45i

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ACTIVA PC

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·August 22, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 17, 2013

    SILICONE ULTRAVIOLET-ABSORBING POSTERIOR CHAMBER THREE PIECE FOLDABLE INTRAOCULA

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL CO.·Product code HQL·October 29, 2010

    ENDURITY DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code DXY·July 8, 2014

    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