BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    Apyx

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

    DELTA XTEND

    FDA UDI
    DEPUY (IRELAND)·10603295115779·DELTA Xtend HUMERAL SPACER TRIAL +9MM

    V-STICK VASCULAR ACCESS SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    250E NDL 23 X 1 A

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code FMI·October 21, 2008

    UNKNOWN DEPUY SROM SLEEVE

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code KWA·September 1, 2011

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·July 17, 2013

    MEDLINE

    FDA Adverse Event
    Malfunction ·SHANGHAI KINDLY ENTERPRISEDEVELOPMENTGROUP CO.,LTD·Product code FMI·June 7, 2024

    The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework. The inner lumen of the covered stent is carbon impregnated.

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·February 15, 2023

    BIOMET StageOne, Hip Cement Spacer Mold w/Reinforcement, 9 X 125 MM, 51 MM, Silicone, Sterile, Item 431209.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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