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

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    Dexcom G6 Pro Continuous Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MW5060579

    FDA Adverse Event
    Malfunction ·February 24, 2016

    INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5

    FDA 510(k)
    FDA Class 2 ·Radiology

    GEM-STONE ABDOMINAL TRAINING SYSTEM; MODEL GEM-TONE 310PE/320PE/330PE/340PE/350PE.

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 22, 2025

    IDENTITY ADX DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, CRMD·Product code LWP·January 13, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 26, 2013

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code MUZ·July 22, 2011

    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