BEUDAMED
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    RICH-MAR MODEL 25 ULTRASOUND

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Alpine SL

    FDA UDI
    Rmo, Inc.·00885797697387·BIO ALPINE SL 018 HK/345 5-5 20 EA

    Novo Surgical

    FDA UDI
    NOVO SURGICAL, INC.·G5869122020·flat caps, gas or steam permeable, can be used ...

    Clear21

    FDA 510(k)
    FDA Class 2 ·Dental

    NUMARIS 4VA15A

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 2, 2010

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code ITJ·January 11, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 3, 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

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021