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

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    Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    BAHADIR STERILIZATION TRAYS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    UNI KNEE SURGETICS NAVIGATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 9, 2024

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·October 10, 2014

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 11, 2013

    AVANTA FLUID MANAGEMENT INJECTION SYSTEM

    FDA Adverse Event
    Injury ·MEDRAD·Product code DXT·July 7, 2011

    Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 782107. 3. Model Number (REF): 782136. 510(k) Numbers: K213516, K223458, K230972, K232030, K251397, K251808

    FDA Enforcement
    Class II ·Ongoing·Philips North America·May 6, 2026