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

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    NIDO™ Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    QLAB Advanced Quantification Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·November 6, 2014

    ARCHITECT TOTAL B-HCG

    FDA Adverse Event
    Malfunction ·A.I.D.D LONGFORD·Product code DHA·September 1, 2011

    4.0MM TI CORTEX EXPANSIONHEAD SCREW SELF-TAPPING 16MM

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code KWP·July 17, 2013

    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 Recall
    Open, Classified ·Philips North America·Product code LNH·April 14, 2026

    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