BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MOMENTS MENOPAUSE CHECK, MODEL 9113

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE·Product code LZG·July 14, 2016

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·November 11, 2014

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·August 24, 2011

    ADVANTAGE SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTN·July 23, 2013

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020