BEUDAMED
    10 results · 36ms · Sources: EU EUDAMED, US FDA

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    SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    cobas c513 Analyzer, cobas c13 Tina-quant HbA1cDx Gen.3 Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PERLA® Posterior Occipito-Cervico-Thoracic Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 23, 2015

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 19, 2014

    CAPTURE-CMV INDICATOR CELLS

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·September 22, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 1, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·February 28, 2012

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·July 23, 2015

    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