BEUDAMED
    8 results · 29ms · Sources: EU EUDAMED, US FDA

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    ACRYDERM ADVANCED WOUND DRESSING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    KINAIR, LOW AIR LOSS BED

    FDA 510(k)
    FDA Class 2 ·General Hospital

    IT XLPE LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·February 15, 2018

    VICTORY XL DR

    FDA Adverse Event
    Death ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·February 5, 2013

    QUILL SRS

    FDA Adverse Event
    Other ·SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)·Product code GAW·December 17, 2010

    STERNUM BLADE

    FDA Adverse Event
    Injury ·STRYKER INSTRUMENTS-KALAMAZOO·Product code DWH·July 18, 2014

    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·May 20, 2015