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

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    TELEFLEX ISIS HVT TRACHEAL TUBE, CUFFED, WITH SUBGLOTTIC SECRETION SUCTION PORT

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450297544·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450576991·

    STATLYTE NA/K/CL/LI ANALYZER

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PANORAMA CENTRAL STATION

    FDA Adverse Event
    Malfunction ·MINDRAY DS USA, INC.·Product code MHX·April 30, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·September 16, 2014

    KRONNER MANIPUJECTOR

    FDA Adverse Event
    Malfunction ·COOPER SURGICAL·Product code LKF·May 5, 2011

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·May 28, 2010

    ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit The MAC(TM) Multi-Lumen Central Venous Access Device with ARROWg+ard Blue(R) permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard(R) technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard(R) antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.

    FDA Enforcement
    Class II ·Terminated·Arrow International Inc·June 14, 2017

    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

    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

    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