BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    BIOFOAM BONE WEDGE MODEL ASSORTED

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NEEDLE 18X1-1/2 RB

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON·Product code FMI·August 5, 2024

    VENTED VIAL ACCESS DEVICE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DORC VITRECTOMY LENSES, MODEL 1284 SERIES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NV MICROCATHETER

    FDA Adverse Event
    Injury ·MICRO THERAPEUTICS, INC. DBA EV3·Product code KRA·July 9, 2020

    TRILOGY 200

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code CBK·August 19, 2020

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·May 1, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 16, 2014

    LIGHTSPEED VCT

    FDA Adverse Event
    Other ·GE MEDICAL SYSTEMS, LLC·Product code JAK·April 22, 2011

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024