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

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    074 Zenith Flex System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FETCH 2 ASPIRATION CATHETER MODEL 109400-001

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    QUADRA-P FEMORAL STEMS

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·November 18, 2025

    ELECTRIC SYSTEMS FOOT CONTROL

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·October 17, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 21, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 27, 2011

    VERSAFITCUP DM DOUBLE MOBILITY HC LINER 50/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·May 17, 2021

    CUP: VERSAFITCUP CC TRIO ACETABULAR SHELL CC TRIO Ø 60

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 10, 2024

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMH

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·January 13, 2023

    BELIFU

    FDA Adverse Event
    Injury ·HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED·Product code GZJ·February 10, 2020

    MPACT ACETABULAR SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·February 6, 2025

    MECTACER BIOLOX DELTA FEMORAL BALL HEAD

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·July 16, 2025

    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

    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis

    FDA Enforcement
    Class II ·Terminated·Synthes, Inc.·July 22, 2015