BEUDAMED
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    syngo.via MI Workflows

    FDA 510(k)
    FDA Class 2 ·Radiology

    AGXO

    FDA UDI
    Oticon A/S·05707131280169·H110, DESIGNRITE 10 WL MOP AGXO

    1.5MM SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036066031·

    PRAXAIR MEDICAL AIR MIXER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013

    STANDARD INSERT

    FDA Adverse Event
    Injury ·DEPUY-RAYNHAM, A DIVISION OF DEPUY ORTHOPAEDICS, INC.·Product code KWA·June 30, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 9, 2008

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016

    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