BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    OPUS(TM) DIGOXIN TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Printed Upper Crown Pack for Herbst UL6

    FDA UDI
    SPECIALTY APPLIANCES, LLC·D8199015470·

    ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP

    FDA 510(k)
    FDA Class 2 ·Microbiology

    NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HARMONIC FOCUS CURVED SHEARS

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·June 18, 2014

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·January 4, 2013

    SJM MASTERS SERIES MECHANICAL HEART VALVE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO, INC. (CS)·Product code LWQ·November 12, 2010

    TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021