BEUDAMED
    9 results · 25ms · Sources: EU EUDAMED, US FDA

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    THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIASTAT ANTI-RO (SS-A)

    FDA 510(k)
    FDA Class 2 ·Immunology

    CEDIA T4

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ENDOLOOP LIGATURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GEA·December 27, 2018

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·June 18, 2014

    CONSULTA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·December 14, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 22, 2013

    Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants

    FDA Enforcement
    Class II ·Terminated·Exactech, Inc.·January 14, 2015

    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021