BEUDAMED
    8 results · 30ms · Sources: EU EUDAMED, US FDA

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    DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I

    FDA 510(k)
    FDA Class 2 ·Radiology

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201502877·LEKSELL STEREOTACTIC SYSTEM CLAMP - SPACER

    REMOTE FETAL MEDICINE ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·HAEMONETICS CORP.·Product code CAC·April 3, 2013

    3 X 3 SUTURABLE DURAGEN

    FDA Adverse Event
    Injury ·INTEGRA LIFESCIENCES·Product code GXQ·May 8, 2008

    PRECISION OPTIUM EZ

    FDA Adverse Event
    Malfunction ·Product code NBW·April 5, 2011

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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