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

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    Vantage Orian 1.5T, MRT-1550, V4.5

    FDA 510(k)
    FDA Class 2 ·Radiology

    SYNAPSE 3D BASIC TOOLS

    FDA 510(k)
    FDA Class 2 ·Radiology

    POWDERED VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·October 22, 2014

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·June 26, 2013

    7900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·July 27, 2011

    OPEN-END FLEXI-TIP URETERAL CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOD·February 6, 2020

    OPEN-END URETERAL CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOD·February 7, 2020

    OPEN-END URETERAL CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code KOD·December 5, 2019

    St. Jude Medical CONFIRM Rx Insertable Cardiac Monitor, Sterile EO, Model #: DM3500 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 Inc.·July 11, 2018

    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