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

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    KSEA SEMM TISSUR PUNCH

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Rad-Sure™

    FDA UDI
    ASHLAND SPECIALTY INGREDIENTS G.P.·00850000065406·Blood Irradiation Indicator

    KIMGUARD ONE-STEP Sterilization Wrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MODIFICATION TO CD HORIZON SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 12, 2016

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE HEALTH SOLUTIONS INC.·Product code LZG·January 18, 2013

    CLEARLINK SYSTEM CONTINU-FLOSOLUTION SET 10DPM LARGE BORE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FMG·December 30, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·July 17, 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