BEUDAMED
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    ARIDYNE 3500

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Medtronic Reusable Instruments

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00721902989629·GUIDE 9790912 DTS

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517330352·CoRoent® SI Ti Markers, 12x17x14 7° Con

    DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900

    FDA 510(k)
    FDA Class 2 ·Radiology

    DRESSING CHANGE KIT

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

    ASR ACETABULAR CUPS 60

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. - 1818910·Product code KWA·May 5, 2014

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Malfunction ·ADVANCED NEUROMODULATION SYSTEMS·Product code LGW·August 6, 2010

    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

    Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    Promote Quadra, Sterile EO, Model # / Part #: CD3221-36/100025054, 60019195; CD3223-36P/100013763; CD3239-40/100029115, 100029254, 100037181; CD3239-40Q/100029116, 100029244, 100037115

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018