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

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    POLYSTAN WIRE REINFORCED TWO STAGE CATHETERS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    THE GENERIC OXYGEN CONCENTRATOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WELLCOGEN BACTERIAL ANTIGEN KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INRATIO PT/INR TEST STRIP

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·April 25, 2014

    FLEXTEND II

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVN·October 19, 2010

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·ANIMAS CORPORATION·Product code LZG·December 16, 2012

    Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·June 8, 2016