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

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    AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES

    FDA 510(k)
    FDA Class 2 ·Neurology

    NIM-ECLIPSE® CONTROLLER

    FDA Adverse Event
    Injury ·MEDTRONIC XOMED, INC·Product code GWF·December 9, 2014

    MedGyn Pessary Cerclage#4 w/o drain

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803050194·Pessary Cerclage is used treat uterine prolapse.

    USB three-button foot switch Kit

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904098630·

    COMFOR-CLINER

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DIGITAL INFLECTION RIGIDOMETER (DIR)

    FDA 510(k)
    FDA Unclassified ·Unknown

    AUTOCAT 2 WAVE JAPANESE

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·April 5, 2013

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    FDA Adverse Event
    Death ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·May 22, 2008

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·April 1, 2011

    BD FACS 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·June 30, 2020

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·May 8, 2025

    BD FACS¿ 7-COLOR SETUP BEADS 25 TESTS

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES·Product code OYE·March 28, 2025

    Hamilton-T1, REF: MSP161339/02, ESM Shielding Set, Spare Part for ventilator

    FDA Enforcement
    Class I ·Ongoing·Hamilton Medical, Inc.·September 27, 2023

    BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Enforcement
    Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020

    BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Enforcement
    Class II ·Terminated·Becton, Dickinson and Company, BD Biosciences·June 17, 2020

    BD FACS Sample Prep Assistant (SPA) II - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019

    BD FACS Sample Prep Assistant (SPA) II Upgrade - Product Usage: K050191: The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II /III is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry.

    FDA Recall
    Terminated ·Becton, Dickinson and Company, BD Biosciences·Product code PER·July 8, 2019