BEUDAMED
    12 results · 32ms · Sources: EU EUDAMED, US FDA

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    Univers Revers Modular Glenoid System, Half Augment Baseplate

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STAT PROFILE PHOX PLUS ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ALLOMATRIX MODEL# 86

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTERSTIM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code EZW·October 6, 2008

    NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, INC. (JUAREZ)·Product code DRF·August 11, 2011

    NATURALYTE

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·October 22, 2014

    ARCOS MOD T HANDLE

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 2, 2013

    GORE VIATORR TIPS ENDOPROSTHESIS

    FDA Adverse Event
    Death ·W. L. GORE & ASSOCIATES, INC.·Product code MIR·June 29, 2021

    PROXIMATE*PPH PROCEDURE SET

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·July 20, 2019

    PROXIMATE*PPH PROCEDURE SET

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·June 21, 2019

    PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code FTL·August 16, 2019

    CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.

    FDA Enforcement
    Class III ·Terminated·Leica Biosystems Richmond Inc.·June 29, 2016