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

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    Catalyst R1 Reverse Shoulder System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EZ-IO INTRAOSSEOUS INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BioShield biopsy valve EUS - Linear

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

    TEMPUS PRO

    FDA Adverse Event
    Malfunction ·REMOTE DIAGNOSTIC TECHNOLOGIES LTD.·Product code MHX·May 5, 2025

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 12, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·September 21, 2023

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·November 13, 2008

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code MDS·August 24, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 18, 2013

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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