BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA

    FDA 510(k)
    FDA Class 2 ·Immunology

    PATIENT EXAM GLOVES (LATEX) MFG. CHINA XINXING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LATEX NON-STERILE EXAM GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    EQUINOXE, HUMERAL HEAD TALL, 44MM (ALPHA)

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWS·July 9, 2024

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·June 25, 2014

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·January 3, 2013

    ORTHADAPT BIOIMPLANT

    FDA Adverse Event
    Injury ·PEGASUS BIOLOGICS, INC.·Product code FTM·November 5, 2010

    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