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

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    CHIRON DIAGNOSTICS ACS:180 TROPONIN I ASSAY (CTNI)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    E-POLY TIBIAL BEARINGS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    InstruSafe(R) Sterilization Container

    FDA 510(k)
    FDA Class 2 ·General Hospital

    E-POLY TIBIAL BEARINGS

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·July 12, 2017

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 25, 2014

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·February 21, 2013

    PRECISION TEST STRIPS

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE, INC. USA·Product code NBW·February 7, 2011

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024