BEUDAMED
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    IMAGEVIEW CORONARY ANGIOGRAPHY DISPLAY AND REVIEW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    artegral

    FDA UDI
    Merz Dental GmbH·D7091972229·posteriors; shade A3.5 light; size XS; lower jaw

    GC85A

    FDA 510(k)
    FDA Class 2 ·Radiology

    MONOSWIFT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SS COMPRESSION HIP SCREW LAG SCREW

    FDA Adverse Event
    Injury ·BIOMET TRAUMA·Product code KTT·September 19, 2016

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·March 28, 2024

    VITROS CHEMISTRY PRODUCTS PHBR SLIDES

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code DLZ·February 21, 2013

    ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYS

    FDA Adverse Event
    Injury ·AMERICAN MEDICAL SYSTEMS, INC.·Product code FTL·January 19, 2011

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·July 31, 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