BEUDAMED
    18 results · 22ms · Sources: EU EUDAMED, US FDA

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    CardioCel 3D

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Sechrist Industries, Inc.

    FDA UDI
    SECHRIST INDUSTRIES, INC.·00852682007521·GURNEY W/STRCH.&MATTRS.JAPANESE,LOW PROFILE

    RHEAD

    FDA UDI
    Stryker GmbH·00886385023687·Standard Stem Trial; Size 4

    Invictus® Bone Cement

    FDA UDI
    TEKNIMED·03701505800528·

    2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDTOX BUPRENORPHINE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    M2A-MAGNUM MODULAR HEAD SIZE 56MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 14, 2013

    ENDOTAK RELIANCE

    FDA Adverse Event
    Malfunction ·CPI - DEL CARIBE·Product code NVY·July 21, 2011

    HEARTSTART FRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 14, 2014

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·February 4, 2020

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·December 4, 2019

    TASUKI

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LOX·June 6, 2019

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·January 2, 2020

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KRA·February 4, 2020

    TRIFORCE¿ PERIPHERAL CROSSING SET

    FDA Adverse Event
    Injury ·COOK INC·Product code KRA·January 2, 2020

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·October 7, 2019

    2CM PERIPHERAL CUTTING BALLOON

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LIT·August 19, 2019

    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