BEUDAMED
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    LEMAITRE BILIARY CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HySil Super Fast Impression Materials

    FDA 510(k)
    FDA Class 2 ·Dental

    CCO SYSTEM MODEL SP1467,SP5567,SP6267

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OCTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·November 5, 2014

    RENEW RECEIVER KIT, 16-CHANNEL

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·February 4, 2015

    FUSION OMNI-TOME PRE-LOADED SPHINCTEROTOME

    FDA Adverse Event
    Malfunction ·WILSON-COOK MEDICAL, INC.·Product code KNS·March 1, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·February 7, 2011

    ENRHYTHM MRI

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·August 8, 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