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

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    THE ORIGINAL PULSE-PAK

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    H-H SHUNT INTRODUCER

    FDA 510(k)
    FDA Class 1 ·Neurology

    INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP

    FDA 510(k)
    FDA Class 2 ·Radiology

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·June 24, 2014

    ACCU-CHEK ® FASTCLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code FMK·July 6, 2015

    HEARTSINE SAMARITAN 300P AND PAD PAK

    FDA Adverse Event
    Malfunction ·HEARTSINE TECHNOLOGIES, LTD·Product code MKJ·December 20, 2012

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014