BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    Juno VPAP ST-A

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    BIOMATE STERILE ACUPUNCTURE NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·November 7, 2023

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code QKP·November 21, 2021

    CAPSUREFIX MRI SURESCAN

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVN·June 8, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 7, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·September 8, 2008

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 2, 2021

    HAKIM PROGRAMMABLE VALVE

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES SWITZERLAND SAR·Product code JXG·March 20, 2024

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code JKA·September 22, 2023

    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of radiation to defined target volumes

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·March 12, 2014

    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