BEUDAMED
    18 results · 36ms · Sources: EU EUDAMED, US FDA

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    GR40CW

    FDA 510(k)
    FDA Class 2 ·Radiology

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704283624·

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 15, 2021

    BINAXNOW COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Injury ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 12, 2021

    BINAXNOW COVID-19 HOME TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 29, 2021

    BRAIN BIOPSY NEEDLE

    FDA 510(k)
    FDA Class 2 ·Neurology

    POWDER FREE VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    XCELA

    FDA Adverse Event
    Malfunction ·PFM MEDICAL CPP SA·Product code LJT·November 7, 2023

    BINAX NOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·August 27, 2021

    COBAS 6000 C (501) MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·January 9, 2017

    PULSE GEN MODEL 103

    FDA Adverse Event
    Death ·CYBERONICS, INC.·Product code MUZ·October 8, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 7, 2011

    PELVICOL ACELLULAR COLLAGEN MATRIX

    FDA Adverse Event
    Injury ·TISSUE SCIENCE LABORATORIES·Product code FTL·May 29, 2013

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 12, 2017

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·December 27, 2016

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·March 10, 2017

    FLEXOR RADIAL ACCESS SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DYB·March 10, 2017

    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