BEUDAMED
    7 results · 23ms · Sources: EU EUDAMED, US FDA

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    GORE BIO-A Tissue Reinforcement

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

    RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FUJINON STERILE OVERTUBES

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

    QUARTET

    FDA Adverse Event
    Injury ·ST JUDE MED, INC. CRMD·Product code DTB·January 13, 2014

    TOTAL ASR ACET IMP SIZE 54

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·June 26, 2013

    R SERIES DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·July 28, 2011

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018