BEUDAMED
    9 results · 23ms · Sources: EU EUDAMED, US FDA

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    EpiMonitor

    FDA 510(k)
    FDA Class 2 ·Neurology

    IRIS Thermocoagulator and Digital Colposcope

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

    ADVANTAGE 4D OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·December 10, 2021

    IMPL TAPERED SCR-V HA 3.7 MM 3.5MM 11.5MM

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·December 10, 2021

    NC TREK CORONARY DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LOX·November 6, 2014

    GORE EXCLUDER AAA ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·W. L. GORE & ASSOCIATES·Product code MIH·July 21, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 18, 2013

    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