BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    MOTILITY CATHETERS

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

    ANGIONEW-IV

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HEARLAB ACA

    FDA 510(k)
    FDA Class 2 ·Neurology

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

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

    REVOLUTION 45MHZ ROTATIONAL IMAGING CATHETER

    FDA Adverse Event
    Malfunction ·VOLCANO CORPORATION·Product code OBJ·January 11, 2011

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Malfunction ·MEDTRONIC SPINE LLC.·Product code NDN·August 26, 2010

    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

    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