BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    ELAN-E DISPOSALBE DRAPE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65888824941·Pediatric Pack

    FlowMet-R

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DRAD3000E/RADREX-I

    FDA 510(k)
    FDA Class 2 ·Radiology

    ST FRANCIS HSP TULSA OK 1

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DTZ·December 18, 2012

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 18, 2014

    HOVEROUND CORPORATION

    FDA Adverse Event
    Injury ·HOVEROUND CORPORATION·Product code ITI·October 20, 2010

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·December 20, 2012

    Pediatric Pack - contains Devon Light Glove Used during surgery

    FDA Enforcement
    Class II ·Completed·Stradis Healthcare, LLC.·July 15, 2015