BEUDAMED
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    Erchonia EVRL

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Trial Cups

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215038878·

    BD LOGIC BLOOD GLUCOSE MONITOR

    FDA Adverse Event
    Other ·BECTON DICKINSON·Product code NBW·January 6, 2006

    COMPUTED TOMOGRAPHY X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    VILEX X-FIX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·September 4, 2018

    SPRINT QUATTRO SECURE S

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·June 7, 2013

    INTEGRITY DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code LWP·January 13, 2014

    PCA SET W/INJECTOR

    FDA Adverse Event
    Malfunction ·HOSPIRA, LTD.·Product code MEA·June 23, 2011

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    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