BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    GORE 3.0T TORSO ARRAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    NEXTAR SPINE

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code OLO·March 28, 2024

    MINICAP

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·August 25, 2011

    ALLEGRETTO WAVE EYE-Q

    FDA Adverse Event
    Injury ·WAVELIGHT GMBH·Product code LZS·October 31, 2014

    LOCKING TITANIUM ADAPTER

    FDA Adverse Event
    Malfunction ·KANAE CO.,LTD.·Product code KDJ·July 12, 2013

    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

    Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

    FDA Enforcement
    Class II ·Ongoing·Spacelabs Healthcare, Inc.·April 15, 2026