BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    BreatheBand® (Model 1000)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813035320·K-Type Files 31MM #45-80

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517415417·CoRoent XLW 15° Trial, 8X22x60mm

    Restore

    FDA UDI
    KEYSTONE DENTAL, INC.·D768L25086000K0·Gold Sleeve

    Restore

    FDA UDI
    KEYSTONE DENTAL, INC.·D768L25086001K0·Gold Sleeve

    Nitroglycerin Sets with DUO-VENT Spike

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GE DATEX-OHMEDA CENTIVA/5 VENTILATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·September 16, 2011

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2014

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 29, 2013

    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