BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X55

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OUR·October 8, 2019

    M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SACRO-ILIAC SCREW SYSTEM SI-JOINT SCREW 10X40

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code OUR·February 5, 2021

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197078009·DEAVER retractor 50x300 mm serrat...

    POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    NEUMOVENT GRAPHNET

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE·Product code DSQ·October 14, 2014

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 21, 2011

    SYNFRAME-EXTENSION W/JOINT

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code LXH·June 15, 2013

    ECHOTIP ULTRA ENDOSCOPIC ULTRASOUND NEEDLE

    FDA Adverse Event
    Malfunction ·COOK ENDOSCOPY·Product code FCG·December 26, 2017

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    ZYSTON IMPLANT, UNKNOWN SIZE OR TYPE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code MAX·August 22, 2020

    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