BEUDAMED
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    CT GAMMA DIALYZER (CT 190G)

    FDA Adverse Event
    Injury ·NISSHO·Product code FJI·April 14, 1998

    MODEL CA-210 DIALYZER

    FDA Adverse Event
    Malfunction ·NISSHO .·Product code FJI·May 7, 1998

    Health Harmony Mobile application software Product Usage: Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home.Care Innovations Health Harmony Mobile is intended as a communication tool to display medical device data from third party devices for patients to view, and to collect assessment (question & answers) from patients in the home. Patients can review their stored vital sign measurements (captured outside of Health Harmony Mobile) and receive educational and motivational content from caregivers.

    FDA Enforcement
    Class II ·Terminated·Intel-GE Care Innovations LLC·July 25, 2018

    CONTINU-FLO SOLUTION SET WITH CONTROL-A-FLO REGULATOR

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FPA·February 10, 1999

    HOMECHOICE AUTOMATED PD SET W/CASSETTE 4 PRONG

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FKX·June 9, 1998

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 16, 2010

    MINICAP DISCONNECT CAP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code KDJ·June 2, 1998

    HOMECHOICE AUTOMATED PD SYSTEM 115 VOLT

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FKX·December 9, 1998

    Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF

    FDA Enforcement
    Class II ·Ongoing·Zyno Medical LLC·March 6, 2024

    INDURA

    FDA Adverse Event
    Malfunction ·MEDTRONIC INC.·Product code LKK·April 9, 2002

    ZYNO MEDICAL Z-800 INFUSION PUMP SYSTEM

    FDA Adverse Event
    Malfunction ·ZYNO MEDICAL, LLC·Product code FRN·August 3, 2022

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·May 11, 2017

    Y-TYPE ADMINISTRATION SET WITH SIDE ARM DRAINAGE TUBE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FKX·July 10, 1998

    SHARPS-A-GATOR

    FDA Adverse Event
    Other ·DEVON INDUSTRIES INC.·Product code MMK·March 27, 1998

    CLEARLINK/CONTINU-FLO/DUO-VENT

    FDA Adverse Event
    Malfunction ·BAXTER INTERNATIONAL INC.·Product code FPA·August 24, 2022

    UV-FLASH GERMICIDAL EXCHANGE DEVICE

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORP.·Product code KDJ·November 5, 1998

    SPS 550

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE CORP.·Product code FKP·June 16, 1998

    CT GAMMA DIALYZER (9CT 190G)

    FDA Adverse Event
    Malfunction ·NISSHO·Product code FJI·September 25, 1998

    CA-HP DIALYZER (CA-HP 210)

    FDA Adverse Event
    Malfunction ·NISSHO 3-9-3·Product code FJI·August 18, 1999

    INTERLINK

    FDA Adverse Event
    Malfunction ·BAXTER INTERNATIONAL INC.·Product code FPA·August 24, 2022