BEUDAMED
    10 results · 21ms · Sources: EU EUDAMED, US FDA

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    GORE Tri-Lumen Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PRO FOCUS 2202, PRO FOCUS 2202 UV MODEL: TYPE 2202

    FDA 510(k)
    FDA Class 2 ·Radiology

    NXSTAGE PUREFLOW SL

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

    BD A-LINE¿

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 14, 2021

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·October 18, 2018

    VUE PACS

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.·Product code LLZ·November 21, 2025

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·June 20, 2013

    UNICEL DXC 600 SYNCHRON SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code CGA·July 1, 2011

    INTELECT ADVANCED 2CH COLOR COMBO W/EMG

    FDA Adverse Event
    Malfunction ·CHATTANOOGA GROUP·Product code IPF·September 29, 2008

    AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

    FDA Enforcement
    Class II ·Ongoing·Fresenius Medical Care Holdings, Inc.·August 3, 2022