BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    CrossBay Endometrial Tissue Sampler (ETS)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ALATUS VAGINAL BALLOON PACKING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERIOSTEAL ELEVATOR, CURVED, 14MM WIDE

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTE·June 27, 2013

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·August 5, 2011

    UNKNOWN DEPUY ACETABULAR LLINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code KWA·October 22, 2014

    ITREL II

    FDA Adverse Event
    Death ·MEDTRONIC NEUROMODULATION·Product code MHY·March 5, 2016

    ITREL II

    FDA Adverse Event
    Death ·MEDTRONIC NEUROMODULATION·Product code MHY·March 5, 2016

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 11, 2018

    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