BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    Echo Intracranial Base Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPB SKIN EMULSION

    FDA 510(k)
    FDA Unclassified ·Unknown

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 19, 2008

    SYS 6 RECIP

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·September 2, 2011

    LYNX SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 22, 2013

    Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.

    FDA Enforcement
    Class II ·Terminated·Applied Medical Resources Corp·May 18, 2016