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

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    CERVICAL COLLAR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    PRESSURE-STAT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TADEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES·Product code LZG·February 20, 2014

    DUROM ACETABULAR COMPONENT 54/48 N

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·October 30, 2012

    TUTOMESH BOVINEPERICARDIUM

    FDA Adverse Event
    Injury ·TUTOGEN MEDICAL GMBH·Product code FTM·June 4, 2015

    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

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

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

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015