BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    SCHOOLTABLE

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AccuCath Intravascular Catheter

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ENPULSE

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code DXY·October 9, 2010

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 20, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code ITI·December 10, 2012

    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