BEUDAMED
    19 results · 23ms · Sources: EU EUDAMED, US FDA

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    EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG)

    FDA 510(k)
    FDA Class 2 ·Immunology

    WILDCAT 7F GUIDEWIRE SUPPORT CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEPARIN ASSAY CONTROLS

    FDA 510(k)
    FDA Class 2 ·Hematology

    TRUWAVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 22, 2026

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·December 6, 2021

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 17, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 21, 2013

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Malfunction ·STAAR SURGICAL COMPANY·Product code HQL·July 28, 2011

    TRUWAVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES DR·Product code DXO·March 27, 2025

    Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

    FDA Enforcement
    Class III ·Terminated·Illumina Inc·December 31, 2014

    TRUWAVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·April 10, 2025

    TRUWAVE

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES DR·Product code DXO·September 5, 2025

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EYB·July 2, 2024

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·February 28, 2022

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·August 29, 2022

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Injury ·COOK INC·Product code EZL·July 8, 2022

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·January 15, 2021

    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