BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

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    BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    AMES TDA PRIMIDONE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CULTURETTE BRAND-PVA/FORMALIN KIT

    FDA 510(k)
    FDA Class 1 ·Pathology

    COROX OTW-L 85-BP

    FDA Adverse Event
    Malfunction ·BIOTRONIK SE & CO. KG·Product code OJX·July 6, 2015

    CURRENT PLUS DR, DF-4 CONNECTOR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·June 24, 2014

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 3, 2010

    DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.

    FDA Enforcement
    Class I ·Terminated·GE Healthcare, LLC·July 30, 2014