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

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    DYNAMICAIRE(TM) SLEEP SURFACE, ZONEAIR(TM) SLEEP SURFACE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ABL80 SC80

    FDA UDI
    Radiometer Medical ApS·05700699457295·SC80 300/15 Full-OX, noGlu, noQC3

    PACING/PSI KIT: 5 FR/6 FR 2-L

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code LDF·April 15, 2015

    AUQASOOTHE/AQUA MED

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    CANMED 451

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·February 6, 2013

    ASR ACETABULAR IMPLANT 50

    FDA Adverse Event
    Injury ·DEPUY INT'L., LTD.·Product code KWA·December 30, 2010

    OT VERIO PRO PLUS METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 21, 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