BEUDAMED
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    FREEDOM PCK COMPONENTS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Cardiovascular Procedure Kit

    FDA UDI
    Terumo Cardiovascular Systems Corporation·00699753473607·

    BIOMERS TRANSLUCENT ORTHODONTIC BRACKET

    FDA 510(k)
    FDA Class 2 ·Dental

    THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUANTA SYSTEM S.P.A.

    FDA Adverse Event
    Malfunction ·QUANTA SYSTEM, S.P.A.·Product code GEX·July 10, 2015

    CLEARVIEW UTERINE MANIPULATOR

    FDA Adverse Event
    Injury ·CLINICAL INNOVATIONS, LLC·Product code LKF·June 11, 2024

    AMISTEM H, HA COATED STEM SIZE 5 STD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 22, 2017

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·October 1, 2014

    GELPORT 120MM

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL·Product code GAD·February 25, 2013

    MAXIMO II VR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code LWS·June 16, 2011

    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