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

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    ICON, MODEL C3

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    POLESTAR N-10

    FDA 510(k)
    FDA Class 2 ·Radiology

    FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·April 29, 2013

    ECHELON 60

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 9, 2011

    ALARIS SYSTEM PUMP MODULE

    FDA Adverse Event
    Other ·CARDINAL HEALTH ALARIS PRODUCTS·Product code FRN·July 23, 2008

    STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

    FDA Enforcement
    Class II ·Terminated·Diagnostica Stago, Inc.·November 14, 2012

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    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