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

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    ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PANORAMIC SCAN, PANORAMIC VIEW, WIDAS, WIDE AREA SCANNING

    FDA 510(k)
    FDA Class 2 ·Radiology

    SILVERLEAF CONTACT WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·April 22, 2024

    ARROW 3-L CVC KIT: 7 FR X 20 CM

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC.·Product code DQY·May 1, 2020

    HEARTMATE II SYSTEM CONTROLLER

    FDA Adverse Event
    Death ·THORATEC CORP.·Product code DSQ·April 30, 2013

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·September 16, 2014

    UNKNOWN SPINAL CORD STIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LGW·May 16, 2011

    SORIN AF 620 W/LOOP 10

    FDA Adverse Event
    Other ·SORIN GROUP USA, INC.·Product code DWE·June 25, 2010

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024