BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    NUFACE MINI DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Oticon

    FDA UDI
    Oticon A/S·05707131264718·RIA PRO, KIT 312 WL DIR 90 R V BE

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·August 15, 2017

    RESPIRONICS CUSTOM II ORAL APPLIANCE

    FDA 510(k)
    FDA Class 2 ·Dental

    HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2024

    JETSTREAM SC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code MCW·January 31, 2023

    ALRIS PCA MODULE ADMINISTRATION SET

    FDA Adverse Event
    Malfunction ·CAREFUSION CORPORATION·Product code FPA·May 1, 2013

    TEMP PUMP TEMPERATURE

    FDA Adverse Event
    Malfunction ·STRYKER CORP DBA GAYMAR·Product code DWJ·May 12, 2011

    UNK

    FDA Adverse Event
    Injury ·I-FLOW CORP.·Product code MEB·August 19, 2008

    VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX

    FDA Enforcement
    Class II ·Terminated·Civco Medical Instruments Co. Inc.·December 29, 2021

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023