BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Advanced Perfusion System 1

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sklar®

    FDA UDI
    SKLAR CORPORATION·10649111285530·TC MAYO DISS SCIS CVD B/B 5.5"

    SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    PRESTIGE 24I; BIOLIS 24I; MGC 240

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ETHICON

    FDA Adverse Event
    Injury ·ETHICON·Product code GAM·July 7, 2011

    OPEN SPINE CLAMP, TITANIUM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC.·Product code HAW·June 11, 2013

    ENDURON 10D 52OD X 28ID

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·October 10, 2014

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020