BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    IMMUNOCARD ROTAVIRUS

    FDA 510(k)
    FDA Class 1 ·Microbiology

    SILVERSEAL

    FDA 510(k)
    FDA Unclassified ·Unknown

    PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    11/13 S-ROM 44MM M SPEC+9

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code LPH·December 17, 2010

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 15, 2014

    IN TOUCH ZU

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·December 21, 2012

    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