BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    Sterile PHALINX Hammertoe System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BARBITURATES

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    EUROIMMUN ANTI-ENA POOL ELISA (IGG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    16MM X 100MM X 8ML BD VACUTAINER® PLUS PLASTIC COLLECTION KIT

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code KDT·November 27, 2017

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·October 29, 2008

    STRETCHER CHAIR

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·July 12, 2011

    ENERGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    SMR CEMENTLESS FINNED STEM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code HSD·February 12, 2024

    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

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023