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

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    Flowart

    FDA 510(k)
    FDA Class 2 ·General Hospital

    CAPTURE-R READY-SCREEN (3)

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·October 27, 2015

    ExoAtlet-II

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GALILEO ECHO

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·December 10, 2015

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·February 17, 2023

    GLIDEWELL HT IMPLANT Ø7.0 X 8 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·December 20, 2024

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·Product code OZO·November 3, 2014

    SUNBEAM

    FDA Adverse Event
    Malfunction ·JARDEN CONSUMER SOLUTIONS, DBA SUNBEAM PRODUCTS·Product code IRT·August 17, 2011

    LIFEVEST WD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORP·Product code MVK·July 2, 2013

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024