BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Dental

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551114321·HALO, CTLSO VEST SMALL, ACRYLIC LINER, 1211-1 S...

    Al-Rad Companion (Pulmonary)

    FDA 510(k)
    FDA Class 2 ·Radiology

    Optiflow Oxygen Kit

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·January 30, 2026

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 17, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 30, 2014

    T-FLEX ASPHERIC

    FDA Adverse Event
    Other ·RAYNER INTRAOCULAR LENSES LTD.·Product code HQL·July 3, 2013

    INVICTUS

    FDA Adverse Event
    Injury ·ALPHATEC SPINE, INC.·Product code NKB·November 21, 2024

    ENDOWRIST

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL, INC·Product code NAY·May 30, 2025

    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