BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    GEN-PROBE MYCOBACTERIUM RAPID CONFIRMATION SYSTEM

    FDA 510(k)
    FDA Class 1 ·Microbiology

    BracePaste Adhesive

    FDA 510(k)
    FDA Class 2 ·Dental

    VERSAJET HYDROSURGERY SYSTEM AND HANDPIECE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PLM A+ SPANISH 110V

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 15, 2014

    TERUMO ADVANCED PERFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEM CORP·Product code DTQ·December 5, 2012

    EDWARDS ASCENDRA+ INTRODUCER SHEATH

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code NPT·June 22, 2015

    Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant

    FDA Enforcement
    Class II ·Ongoing·MED-EL Elektromedizinische Gereate, Gmbh·July 24, 2024

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012