BEUDAMED
    14 results · 17ms · Sources: EU EUDAMED, US FDA

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    GIP/MEDI-GLOBE SCLEROTHERAPY NEEDLES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·May 4, 2022

    PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code KDI·March 15, 2022

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code KDI·January 7, 2021

    IAS ANESTHESIA MASK

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    INFILTUBE

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

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    RUSCH EB ROBERTSHAW LEFT 37F

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code BTS·June 13, 2014

    COAGUCHEK® XS SYSTEM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code GJS·February 11, 2013

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 10, 2011

    PRISMAX MACHINES

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·October 10, 2023

    PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

    FDA Recall
    Open, Classified ·VANTIVE US HEALTHCARE LLC·Product code KDI·July 28, 2025

    PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, 955627, 955701

    FDA Enforcement
    Class II ·Ongoing·VANTIVE US HEALTHCARE LLC·September 3, 2025

    Hemodialysis Delivery System, Software Version 2.x.

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·November 17, 2021