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

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    CREA OR CREATININE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    DOCTOR'S LIGHT LED DENTAL CURING LIGHT

    FDA 510(k)
    FDA Class 2 ·Dental

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·January 18, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 27, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 31, 2014

    REMINGTON MEDICAL DISPOSABLE PACING CABLE

    FDA Adverse Event
    Malfunction ·REMINGTON MEDICAL·Product code DSA·September 13, 2002

    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