BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    Saneso Lens Wash Bottle Assembly (SAN-LWB-A)

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

    ONE TOUCH PROFILE

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·February 8, 2002

    Pulse Oximeter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DIGITAL FLAT PLANEL X-RAY DETECTOR / 1717SCC

    FDA 510(k)
    FDA Class 2 ·Radiology

    BD INSYTE AUTOGUARD

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·March 3, 2025

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 24, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 12, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·November 13, 2015

    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

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025