BEUDAMED
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    PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    WiZARD 310/320 Series CPAP Mask

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ASR ACETABULAR CUPS 56

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·February 28, 2013

    COULTER LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code GKZ·August 6, 2014

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·January 14, 2011

    INFLATOR KIT 18INFKIT BALLOON

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code LRC·August 15, 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