BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    OASIS MRI System

    FDA 510(k)
    FDA Class 2 ·Radiology

    NXSTAGE PUREFLOW SL

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

    PERLA® Posterior Occipito-Cervico-Thoracic Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 28, 2025

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·November 10, 2014

    ASR UNI FEMORAL IMPL SIZE 43

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·September 9, 2011

    2.5MM X 25.4MM FLUTED ROUTER

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code GFF·July 17, 2013

    REVERSE SHOULDER SYSTEM LAT. GLENOSPHERE 39XØ27

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code HSD·March 26, 2024

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021