BEUDAMED
    11 results · 24ms · Sources: EU EUDAMED, US FDA

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    AFFIRM VP SAMPLE COLLECTION SET

    FDA 510(k)
    FDA Class 1 ·Microbiology

    HEART SYNC PEDIATRIC PHYSIO AED PAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    GAZELLE WHEELCHAIR

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SECONDARY IV SET-SL/CE (50/CS)

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FPA·March 12, 2012

    PORTE8X NEONATAL/PEDIATRIC INTUBATION SYSTEM WITH STANDARD CONNECTOR

    FDA Adverse Event
    Injury ·SMITHS MEDICAL INTERNATIONAL LTD.,·Product code BTR·December 6, 2010

    VERITY DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWP·July 8, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·December 7, 2012

    PROWLER SELECT PLUS 150/5CM

    FDA Adverse Event
    Death ·MEDOS INTERNATIONAL SARL·Product code KRA·August 30, 2023

    EU ENT4.5MMD 22MML WNO DSTL TP

    FDA Adverse Event
    Death ·MEDOS INTERNATIONAL SARL·Product code NJE·August 30, 2023

    INTER-LOCK SCREWDRIVER T25/3.5MM HEX/224MM

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HXX·October 30, 2019

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021