BEUDAMED
    14 results · 41ms · Sources: EU EUDAMED, US FDA

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    Masimo Acoustic Respiration Sensors, infant and neonate

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    FUJIFILM ENDOSCOPIC CO2 REGULATOR

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

    NOBELCLINICIAN

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 7, 2025

    1823260-2017-01778

    FDA Adverse Event
    Malfunction ·August 21, 2017

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·October 1, 2014

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 17, 2013

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code HQL·July 24, 2011

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·September 3, 2024

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE·Product code FDF·July 22, 2016

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD.·Product code FCX·July 22, 2016

    THORATEC® HEARTMATE 3¿ VAD MODULAR CABLE

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·April 9, 2025

    FUJIFILM

    FDA Adverse Event
    Death ·FUJIFILM TECHNO PRODUCTS CO., LTD. MITO SITE·Product code FDS·July 22, 2016

    Cook Lead Clipper- An auxiliary tool indicated for use in patients requiring percutaneous retrieval of cardiac leads. Order Number (GPN): G20003 Reference Part Number (RPN): LR-CLP001

    FDA Enforcement
    Class II ·Ongoing·Cook Vandergrift, Inc.·September 13, 2023