BEUDAMED
    10 results · 23ms · Sources: EU EUDAMED, US FDA

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    eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)

    FDA 510(k)
    FDA Class 2 ·General Hospital

    PHILIPS DRUG CALCULATOR SOFTWARE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    B Dispensing Line

    FDA 510(k)
    FDA Class 2 ·General Hospital

    GLOVE SURGICAL PROTEXIS PI

    FDA Adverse Event
    Injury ·CARDINAL HEALTH (THAILAND) 222 LIMITED·Product code KGO·November 4, 2014

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·August 25, 2011

    PFC SIGMA TIB TRAY CEM SZ3

    FDA Adverse Event
    Injury ·1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC·Product code JWH·July 12, 2013

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·March 19, 2024

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·March 19, 2024

    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