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    VANTAGE TITAN 3T

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    LEKSELL GAMMAPLAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    PALL ULTIPOR ANESTHESIA BREATHING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 15, 2024

    INFINION 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 13, 2021

    BIPAP A30-S SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    BIPAP A30, SILVER

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code MNS·September 25, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 12, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 12, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 11, 2024

    CARDINALHEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 13, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 12, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 13, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 12, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·3005670221-2024-00010 CARDINAL HEALTH JIA·Product code FMF·April 12, 2024

    CARDINAL HEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 11, 2024

    CARDINALHEALTH

    FDA Adverse Event
    Malfunction ·JIANGSU CAINA MEDICAL CO., LTD.·Product code FMF·April 11, 2024

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 9, 2013

    IMPAX CV OUTBOUND (RESULTS MANAGEMENT 2.08)

    FDA Adverse Event
    Malfunction ·AGFA HEALTHCARE CORP.·Product code LLZ·February 28, 2014