BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

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    HS40 Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    CRIT-LINE CLIP (CLIC)

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

    96 CHANNEL EEG HEADBOX MODEL EMU96

    FDA 510(k)
    FDA Class 2 ·Neurology

    CAPTURE-R READY-SCREEN I AND II

    FDA Adverse Event
    Malfunction ·IMMUCOR, INC.·Product code KSZ·April 21, 2016

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·November 3, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP·Product code FRN·July 3, 2013

    CAPSURE Z

    FDA Adverse Event
    Injury ·MEDTRONIC, INC.·Product code DTB·June 24, 2021

    CAPSURE Z

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DTB·June 24, 2021

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021