BEUDAMED
    15 results · 27ms · Sources: EU EUDAMED, US FDA

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    Hammertoe Correction System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    OPUS SPEEDSCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ICON (TM) MODULAR PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VERSYS FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code LPH·February 25, 2016

    INCORPORATE

    FDA UDI
    SPINAL ELEMENTS·00840606151993·17 X 14 CERVICAL TRIALS 48MM 0° LORDOSIS

    INCORPORATE

    FDA UDI
    SPINAL ELEMENTS·00840606152181·17 X 14 CERVICAL TRIALS 48MM 10° LORDOSIS

    VC10 PUMP, 115V

    FDA Adverse Event
    Malfunction ·GYRUS ACMI, INC.·Product code HHK·January 2, 2025

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·October 14, 2014

    OT ULTRA METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 15, 2013

    TWIST DRILL FOR 6MM SCREWS, DIAM.1.0X50MM, WL 7MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code HBE·June 30, 2011

    UNKNOWN

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·July 26, 2024

    ROADRUNNER EXTRA-SUPPORT BARE MANDRIL WIRE GUIDE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQX·January 19, 2021

    StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.

    FDA Enforcement
    Class II ·Terminated·Dental EZ Stardental Division·June 19, 2013

    CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-0105-50L l. 21-2127-0105-02L m. 21-2127-0105-06L n. 21-2127-0105-50L

    FDA Enforcement
    Class I ·Terminated·Smiths Medical ASD Inc.·October 27, 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