BEUDAMED
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    MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65888823941·Arthrogram Tray

    WiZARD 310/320 Series CPAP Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MRI GENTAMICIN RIA KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    COULTER LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·June 18, 2014

    LEVEL 1 FAST FLOW FLUID WARMER

    FDA Adverse Event
    Death ·SMITHS MEDICAL ASD, INC.·Product code KZL·October 21, 2010

    5.5MM TI MIN INVASIVE CURVED ROD 100MM RADIUS/35MM

    FDA Adverse Event
    Injury ·SYNTHES GMBH·Product code NKB·December 20, 2012

    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 System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020