BEUDAMED
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    TRICYCLICS SERUM TOX ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EMIT COLUMN DIGOXIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Reprocessed Orbiter ST Steerable Diagnostic EP Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·January 18, 2013

    RESTORE ULTRA MRI

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 28, 2014

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES·Product code MIH·January 10, 2011

    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