BEUDAMED
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    Surveyor Patient Monitor

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Dandy Clear Aligners

    FDA UDI
    Orthly, Inc.·00860006891206·

    GUIDEZILLA GUIDE EXTENSION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MAC 600 RESTING ECG ANALYSIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCU-CHEK ® TENDER INFUSION SET

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FPA·October 15, 2014

    NX3

    FDA Adverse Event
    Injury ·KERR CORPORATION·Product code EMA·June 17, 2013

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 24, 2011

    Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·November 29, 2017

    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