BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    SICKLE-HEME A/S HETEROZYGOUS CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power

    FDA 510(k)
    FDA Class 2 ·Radiology

    CUTICOVER SKIN BARRIER DEVICE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 13, 2014

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·November 21, 2012

    TMJ LARGE RIGHT FOSSA COMPONENT

    FDA Adverse Event
    BIOMET MICROFIXATION·Product code LZD·September 23, 2010

    BIOLO OPTION, HEAD, XL¸ 36/+7, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·July 9, 2019

    Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); b. Vantage Mobile-Bearing Polyethylene Liner Component (Product Line: 350-41-XX, 350-42-XX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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