BEUDAMED
    12 results · 28ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Black Diamond Pedicle Screw System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ECHO BI-METRIC HIP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304492264·

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583033174·ET20, KIT 10 NFM 75 PB BE ENCHANT 20

    Echo® Bi-Metric® Hip System

    FDA UDI
    Biomet Orthopedics, LLC·00887868260674·

    ERGOSELECT/GE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ECLIPSE VERTEBRAL SPACER SYSTEM-LUMBAR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 27, 2013

    SUBQ

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWS·August 4, 2011

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code MUZ·October 7, 2008

    Various products which were contract sterilized.

    FDA Enforcement
    Class II ·Ongoing·Anewmed Corporation·November 6, 2019

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    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