BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    AN3000 MAHONEY DRAIN

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    ADHEAR System

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 13, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·October 8, 2010

    QUANTUM SYSTEM

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GEI·December 11, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015