BEUDAMED
    7 results · 20ms · Sources: EU EUDAMED, US FDA

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    CRITIFLO & CRITIFLO DOME

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Fidmi Low Profile Enteral Feeding Device

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CONSTELLATION VISION SYSTEM

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·January 22, 2014

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·October 15, 2012

    ATTAIN OTW

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·August 10, 2010

    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024