BEUDAMED
    8 results · 24ms · Sources: EU EUDAMED, US FDA

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    Dexcom G7 Continuous Glucose Monitoring System

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    neo315

    FDA 510(k)
    FDA Class 2 ·Radiology

    Plenity

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

    Access Hybritech p2PSA reagent, REF B03704 and REF A49752.

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·July 5, 2023

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVAMEX·Product code ITI·November 7, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·August 30, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 18, 2013

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020