BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    OLYMPUS AMYLASE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DENTOMAT 3 AMALGAMATORS

    FDA 510(k)
    FDA Class 1 ·Dental

    COZART EIA OPIATES ORAL FLUID KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·January 22, 2013

    SJM MECHANICAL HEART VALVE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO, INC. (CS)·Product code LWQ·December 7, 2010

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·July 9, 2014

    Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024