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    MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Lippy

    FDA UDI
    MEDTRONIC XOMED, INC.·00681490034623·PROSTHESIS 1133260 LIPPY CUP PSTN .6X5.0

    N/A

    FDA UDI
    MEDTRONIC XOMED, INC.·00763000035235·PROSTHESIS 1133260 LIPPY CUP PSTN .6X5.0

    Oticon

    FDA UDI
    Oticon A/S·05707131259875·RIA PRO, BTE 13 WL 100 DBL

    VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AEQUOS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    U-BLADE SET, TI GAMMA3 10.5X100MM

    FDA Adverse Event
    Injury ·STRYKER OSETOSYNTHESIS KIEL·Product code HSB·December 18, 2012

    T:SLIM G5 SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code OYC·February 6, 2019

    CORAIL2 STD SIZE 9

    FDA Adverse Event
    Injury ·3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST·Product code KWA·May 29, 2013

    AUTOSONIX ULTRA SHEARS 5MM INSTRUMENT

    FDA Adverse Event
    Malfunction ·UNITED STATES SURGICAL·Product code LFL·May 11, 2011

    PUMP MMT-512NAB PRDGM INSULIN BL EN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·August 21, 2008

    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