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

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    CERVICAL BRACE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LILY Extension Tube and Needleless Connector

    FDA 510(k)
    FDA Class 2 ·General Hospital

    JACKSON HYDRO SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYMBIQ SINGLE CHANNE

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·February 7, 2014

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·HAEMONETICS CORP.·Product code CAC·November 2, 2012

    UNKNOWN DEPUY CERAMIC 28+5 HEAD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code MRA·August 25, 2010

    OSS POLY TIBIAL BUSHING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·February 13, 2020

    OSS POLY LOCK PIN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·February 13, 2020

    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