BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    SPECIALTY ASSAYED CONTROL-1

    FDA 510(k)
    FDA Class 2 ·Hematology

    CONVENTUS PHS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)

    FDA 510(k)
    FDA Class 2 ·Radiology

    TERUMO PERFUSION SYSTEM 8000

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code JOR·December 20, 2010

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 17, 2014

    AUTOPULSE NIMH BATTERY

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION, INC.·Product code DRM·December 27, 2012

    PKG, 5MM X 33CM INSERT, DISSECTING FORCEPS, P/N 0250080760 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014