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    PowerDot PD-01MT2 Muscle Stimulator

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    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

    Pilon Plate, Small

    FDA UDI
    I.T.S. GmbH·09120034305009·Pilon Plate, Small, 8-Hole

    SYNGO MULTIMODALITY WORKSTATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    THE PL-1064 LASER SYSTEM

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

    THERMACHOICE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code MKN·November 19, 2007

    I-STAT ACT KAOLIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JBP·February 6, 2015

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523171477·RM/LL HXL PE w/ Vitamin E TRIBRID Tibial Insert...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523171699·RM/LL HXL PE w/ Vitamin E TRIBRID Tibial Insert...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523171590·RM/LL HXL PE w/ Vitamin E TRIBRID Tibial Insert...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523171569·RM/LL HXL PE w/ Vitamin E TRIBRID Tibial Insert...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523171767·RM/LL HXL PE w/ Vitamin E TRIBRID Tibial Insert...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523171811·RM/LL HXL PE w/ Vitamin E TRIBRID Tibial Insert...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523171866·RM/LL HXL PE w/ Vitamin E TRIBRID Tibial Insert...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523171644·RM/LL HXL PE w/ Vitamin E TRIBRID Tibial Insert...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523171491·RM/LL HXL PE w/ Vitamin E TRIBRID Tibial Insert...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523171736·RM/LL HXL PE w/ Vitamin E TRIBRID Tibial Insert...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523171545·RM/LL HXL PE w/ Vitamin E TRIBRID Tibial Insert...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523171828·RM/LL HXL PE w/ Vitamin E TRIBRID Tibial Insert...

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523171507·RM/LL HXL PE w/ Vitamin E TRIBRID Tibial Insert...