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

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    ENFit enteral syringes (NUTRIFIT)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CONCORD 88

    FDA 510(k)
    FDA Class 2 ·Dental

    ARTHREX SCAPHOLUNATE ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 5, 2025

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·October 29, 2014

    PRIMEWIRE PRESTIGE PRESSURE GUIDE WIRE

    FDA Adverse Event
    Malfunction ·VOLCANO CORPORATION·Product code DQX·August 5, 2011

    INTRALASE FS2

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HNO·July 8, 2013

    CAPTURE-R READY-SCREEN 3

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·December 16, 2015

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021