BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    HILAR

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Family of Venus RF Systems - Heal

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BARD PTFE (TEFLON) COATED GUIDE WIRES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FGE·April 30, 2014

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 27, 2007

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Injury ·COOK, INC.·Product code DQY·October 3, 2012

    Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry, electrolytes, total magnesium, and metabolites, (Glucose and Lactate).

    FDA Enforcement
    Class III ·Terminated·Smiths Medical ASD, Inc.·February 4, 2015

    ACCOLADE SR SL MRI (Model L310)

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