BEUDAMED
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    PERCUTANEOUS NEPHROSTOMY SETS (OTTO)

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    THREADED TITANIUM METAL BACKED ACETABULAR CUP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TACTILE PLUS DENTAL ELEVATORS

    FDA 510(k)
    FDA Class 1 ·Dental

    BD ULTRA FINE 31G X 8MM INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BD·Product code FMI·May 28, 2014

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 5, 2010

    RESTORE ADVANCED

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·December 3, 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