BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEPHROSTOMY/BILIARY DRAINAGE BAG

    FDA 510(k)
    FDA Unclassified ·Unknown

    PORTABLE DIAGNOSTIC LABORATORY

    FDA 510(k)
    FDA Class 1 ·Microbiology

    POLYFLUX 210H

    FDA Adverse Event
    Injury ·GAMBRO DIALYSATOREN GMBH·Product code KDI·June 25, 2014

    THORACIC SCREW BONE AWL, SS

    FDA Adverse Event
    Malfunction ·ALPHATEC SPINE INC·Product code KWP·November 9, 2010

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP·Product code CBK·December 27, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025