BEUDAMED
    7 results · 34ms · Sources: EU EUDAMED, US FDA

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    MID-STREAM COLLECTION SET-STERILE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PREMIUM PLUS CEEA 25 INSTR. W/TILT-TOP

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC PUERTO RICO·Product code GDW·February 6, 2013

    FINELINE II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·January 10, 2011

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·July 23, 2014

    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020