BEUDAMED
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    FORMULATION HWS-256 EPA REG. NO. 47371-129

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BASE

    FDA UDI
    Nuvasive, Inc.·00887517701138·BASE Ti Implant, 10x42x30mm 10°

    DeBakey Aortic Aneurysm Clamps

    FDA UDI
    KOROS U.S.A., INC.·10840199540119·DeBakey Aortic Aneurysm Clamps 26.5cm10-1/2"

    iNSitu™ Hip System

    FDA UDI
    NEXTSTEP ARTHROPEDIX, LLC·00816127023200·Lateralizing Reamer

    Hudson RCI AquaPak Sterile Prefilled Nebulizers

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    VISTADENT AT COMPLETE, MODEL 3.1

    FDA 510(k)
    FDA Class 2 ·Radiology

    VIRTUOSO DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 9, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·July 23, 2014

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 7, 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