BEUDAMED
    16 results · 39ms · Sources: EU EUDAMED, US FDA

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    UPJ Occlusion Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UPJ OCCLUSION BALLOON CATHETER

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

    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

    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

    ARTUS INFL A/B RG RT-PCR KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    NUVO VERDE LED LIGHTING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·July 28, 2011

    TOTAL ASR ACET IMP SIZE 48

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL LTD.·Product code KWA·June 21, 2013

    HOSPIRA

    FDA Adverse Event
    HOSPIRA GLOBAL MEDICAL AFFAIRS·Product code FPA·September 22, 2008

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 18, 2023

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·December 7, 2023

    ATLAS GOLD

    FDA Adverse Event
    Malfunction ·BARD PERIPHERAL VASCULAR, INC.·Product code DQY·November 14, 2023

    V-Twin, Catalog # 6002-800, UDI: 03661540600180 - Product Usage: An in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

    FDA Enforcement
    Class II ·Terminated·Vital Scientific N.V.·October 16, 2019

    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