BEUDAMED
    11 results · 30ms · 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.

    EUB-310 ULTRASONIC SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL QT1JC1

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MagDen Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code OUT·September 30, 2016

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code OUT·September 30, 2016

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·December 10, 2012

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·February 19, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·June 23, 2015

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Injury ·COVIDIEN (IRVINE)·Product code OUT·June 12, 2016

    PIPELINE EMBOLIZATION DEVICE

    FDA Adverse Event
    Death ·COVIDIEN (IRVINE)·Product code OUT·September 30, 2016

    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