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

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    RI-MED

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    A4 Const. Class B 21 - 36 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588252971·A4 Const. Class B 21 - 36 Metal

    DIAVENTIONAL CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TROCAR & TROCAR SLEEEVE 11MM, 10MM, 8MM & 5MM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 22, 2013

    KAPPA 900 DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL, INC.·Product code DXY·December 14, 2010

    NC QUANTUM APEX?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·July 10, 2014

    ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020

    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021