BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    EM SINUS DILATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    INFLATOR KIT 18INFKIT BALLOON

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014

    BALLOON SEEKER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED INC.·Product code LRC·August 15, 2014

    AGXO

    FDA UDI
    Oticon A/S·05707131257932·H160, MINIBTE 312 WL 85 STG AUDIGY

    ENLUXTRA HUMIFIBER WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    DISPOSABLE N-PE MICKROKERATOME BLADES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CORDLESS DRIVER HIGH SPEED BUR ATTACHMENT

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS-KALAMAZOO·Product code HRX·May 29, 2013

    SYSTEM 6 ASEPTIC HOUSING ASSY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·June 11, 2011

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·October 1, 2014

    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

    FDA Enforcement
    Class II ·Terminated·Zimmer Dental Inc·February 5, 2014

    Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Number TSVWB11, Lot 62470008. Class II, 510(k) K13227.

    FDA Recall
    Terminated ·Zimmer Dental Inc·Product code DZE·January 6, 2014

    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