BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    HOSPAL BLOOD LINES

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

    ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    A16 BLOOD FLOW MEASUREMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COBAS 8000 C 702 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 3, 2025

    INTERMATE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - IRVINE·Product code FRN·May 21, 2014

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·October 10, 2012

    HIRES 90K ADVANTAGE IMPLANT

    FDA Adverse Event
    Injury ·ADVANCED BIONICS LLC·Product code MCM·June 4, 2015

    Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Enforcement
    Class II ·Ongoing·Electro Medical Systems SA·May 1, 2024

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024