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

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    MEDICAL TREATMENT CHAIR, T400, T500,T600

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    TRANSSEPTAL NEEDLE/TROCAR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODIFICATION TO BLEASE FRONTLINE GENIUS RANGE, ANESTHESIA MACHINES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TROCAR

    FDA Adverse Event
    Injury ·MERIT MEDICAL SYSTEMS, INC.·Product code DYB·June 5, 2018

    BENEVIEW MONITOR

    FDA Adverse Event
    Malfunction ·SHENZHEN BIOMEDICAL ELECTRONICS CO.·Product code MHX·April 30, 2013

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·August 20, 2014

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS LLC (PR)·Product code NIQ·May 17, 2011

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·May 7, 2019

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·September 25, 2018

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·September 26, 2018

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQY·July 14, 2017

    UPJ OCCLUSION BALLOON CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZN·April 7, 2017

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·July 8, 2019

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump

    FDA Enforcement
    Class I ·Ongoing·ARROW INTERNATIONAL Inc.·December 21, 2022

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·November 14, 2017

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·November 19, 2018

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·July 19, 2018

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·August 1, 2018

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·August 22, 2018

    UNIVERSA SILICONE FOLEY CATHETER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code EZL·February 21, 2018