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

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    Instrument Case P1340904

    FDA 510(k)
    FDA Class 2 ·General Hospital

    INION FREEDOMSCREW (ALTERNATIVE MARKETING NAME: INION OTPS FREEDOMSCREW)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    X O ODONTOSURGE 4

    FDA 510(k)
    FDA Class 2 ·Dental

    INION OTPS BIOABSOBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·November 18, 2014

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 14, 2025

    INION OTPS BIOABSOBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·May 14, 2015

    INION OTPS BIOABSORBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·March 19, 2015

    ESPRIT VENTILATOR

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

    AQUACEL FOAM DRESSING

    FDA Adverse Event
    Injury ·CONVATEC INC.·Product code FRO·October 31, 2014

    UNKNOWN J&J TC1 TIBIAL INSERT

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JWH·July 12, 2013

    INION OTPS BIOABSORBABLE FREEDOMPLATE

    FDA Adverse Event
    Injury ·INION OY·Product code HRS·June 5, 2015

    Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

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