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

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    ENDOCHOICE WATER BOTTLE CAP SYSTEM

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

    NT 2000 LESIONING GENERATOR

    FDA 510(k)
    FDA Class 2 ·Neurology

    CIC-C1Q EIA

    FDA 510(k)
    FDA Class 2 ·Immunology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 14, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 24, 2014

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 3, 2011

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·February 27, 2025

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L231, PROPONENT DR EL MRI Pacemaker

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