BEUDAMED
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    Dental Impression Material

    FDA 510(k)
    FDA Class 2 ·Dental

    NITRILE EXAMINATION GLOVES POWDERFREE (BLUE COLOR)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    VarseoSmile Crown plus

    FDA 510(k)
    FDA Class 2 ·Dental

    CADD SOLIS VIP

    FDA Adverse Event
    Malfunction ·ST PAUL·Product code MEA·April 21, 2022

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    FDA Adverse Event
    Malfunction ·STRYKER ORTHOPAEDICS-MAHWAH·Product code HTO·November 3, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    SYNCARDIA COMPANION 2 DRIVER

    FDA Adverse Event
    Malfunction ·SYNCARDIA SYSTEMS, INC.·Product code LOZ·July 1, 2013

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025