BEUDAMED
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    MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    QUICKVUE INFLUENZA A+B

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SODIUM HYPOCHLORITE 7%

    FDA 510(k)
    FDA Class 1 ·Pathology

    IMPELLA RP FLEX

    FDA Adverse Event
    Malfunction ·ABIOMED, INC.·Product code PYX·January 6, 2026

    GOBED II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code FNL·January 28, 2013

    ENSEAL ROUND TIP

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY·Product code GEI·December 13, 2010

    VIVA QUAD XT

    FDA Adverse Event
    Death ·IPG MFG SWITZERLAND·Product code NIK·July 14, 2014

    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