BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TALOS® IBF

    FDA UDI
    MEDITECH SPINE, LLC·B16711411260·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587P1411260·14mm PLIF Implant 11mm Wide 26mm Length

    Ardis®

    FDA UDI
    ZIMMER SPINE, INC.·00889024333932·

    Ardis®

    FDA UDI
    ZIMMER SPINE, INC.·00889024334663·

    Yellowstone

    FDA UDI
    SUMMIT SPINE LLC·B587P14112670·14mm PLIF Implant 11mm Wide 26mm Length 7 Degrees

    PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPTI CCA-TS2

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 24, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·June 22, 2011

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 3, 2008

    MYAIRVO HUMIDIFIER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·February 4, 2016

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·March 26, 2015

    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