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    DISCOVERY IGS 740

    FDA 510(k)
    FDA Class 2 ·Radiology

    Walgreens

    FDA UDI
    WALGREEN CO.·00311917209340·WALG ADJ FOLDING CANE

    RANDOX URIC ACID

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM; ACURA PLUS BLOOD GLUCOSE METER; ACURA CONTROL SOLUTION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ACTIV.A.C.¿ THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 12, 2018

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ILS·May 29, 2013

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC·Product code CBK·May 11, 2011

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·June 8, 2021

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 14, 2021

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·October 3, 2023

    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

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015