BEUDAMED
    7 results · 21ms · Sources: EU EUDAMED, US FDA

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    Cervical Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CERVEX-BRUSH COMBI

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    MRidium 3860+ MRI infusion Pump/ Monitoring System

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ENSEAL G2 ARTICULATING

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GEI·November 11, 2014

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 12, 2011

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    FDA Adverse Event
    Malfunction ·ETHICON INC.·Product code GAM·July 23, 2013

    PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. 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