BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    SARTOPHOR SYSTEM FOR ELECTROPHORESIS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Tranquil-L™

    FDA UDI
    NEXUS SPINE, L.L.C.·B6788231320·14 mm Small Hudson Shaver, 6mm wide

    JOSTRA MECC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HEARTSTART HOME

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code NSA·February 5, 2014

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·November 7, 2012

    ACCESS® 2 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code MMI·September 1, 2010

    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