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

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    SD1 Ultrasonic Pocket Doppler

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

    Epredia

    FDA UDI
    SHANDON DIAGNOSTICS LIMITED·05051663517805·CTM6 coverslipper- Accessory

    MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR

    FDA 510(k)
    FDA Class 2 ·Radiology

    CONFORMIS ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMK SPHERE TIBIAL INSERT

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·July 30, 2018

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 6, 2025

    SYNCHRON LX®20 PRO CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 22, 2011

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·May 31, 2013

    BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER

    FDA Adverse Event
    Other ·BECTON DICKINSON INFUSION THERAPY SYSTEMS·Product code LJS·September 18, 2008

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·July 26, 2019

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·June 27, 2024

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    FDA Adverse Event
    Injury ·COOK INC·Product code DYB·March 29, 2022

    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·April 26, 2017

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020