BEUDAMED
    12 results · 20ms · Sources: EU EUDAMED, US FDA

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    MICRO-X 15 HF

    FDA 510(k)
    FDA Class 1 ·Radiology

    DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD, INC.·Product code BTO·April 26, 2017

    PORTEX® BIVONA® UNCUFFED NEONATAL TRACHEOSTOMY TUBE

    FDA Adverse Event
    Injury ·SMITHS MEDICAL ASD, INC.·Product code BTO·April 13, 2017

    BIVONA® UNCUFFED PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code JOH·August 18, 2016

    V60 VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC·Product code MNT·July 14, 2015

    EASYDIAGNOST ELEVA

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code KPR·November 12, 2010

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·July 3, 2014

    BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE

    FDA Adverse Event
    Injury ·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code JOH·February 29, 2024

    BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL ASD INC.·Product code BTO·August 15, 2016

    Pipeline Flex Embolization Device

    FDA Enforcement
    Class I ·Ongoing·Micro Therapeutics Inc,·September 15, 2021