BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    MULTI-TEST

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SYNVITRO CUMULASE (HYALURONIDASE MEDIUM)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    VIRTU Lumbar Spacer System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·April 11, 2014

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·September 26, 2012

    AIR OPTIX NIGHT & DAY AQUA

    FDA Adverse Event
    Injury ·PT. CIBA VISION BATAM·Product code LPM·July 15, 2010

    NEEDLE 25X1 RB

    FDA Adverse Event
    Malfunction ·BD MEDICAL (BD WEST) MEDICAL SURGICAL·Product code FMI·February 21, 2019

    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