BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Surgical Face Mask

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 3, 2014

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·August 24, 2011

    PAINSMART IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·July 5, 2013

    PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. 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