BEUDAMED
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    ULTIMATE SEAL

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994172037·PLATE 9960401 TORQUE LIMITING NUT DRIVER

    Eye Shield

    FDA UDI
    KATENA PRODUCTS, INC.·00841668111161·FOX EYE SHIELD GARTERS WHITE PACK OF 50

    MEDRAD 3.0T ECOIL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    Tyto Stethoscope

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARTSTART ONSITE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·January 25, 2013

    RESTORE RECHARGABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·December 16, 2010

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·July 17, 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