BEUDAMED
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    RIGID PNEUMATIC PROBE

    FDA Adverse Event
    Malfunction ·ELECTRO MEDICAL SYSTEMS SA·Product code FFK·March 8, 2023

    RIGID PNEUMATIC PROBE

    FDA Adverse Event
    Malfunction ·ELECTRO MEDICAL SYSTEMS SA·Product code FFK·March 8, 2023

    RIGID PNEUMATIC PROBE

    FDA Adverse Event
    Malfunction ·ELECTRO MEDICAL SYSTEMS SA·Product code FFK·March 8, 2023

    EMS SWISS LITHOCLAST LITHOTRIPTER

    FDA Adverse Event
    Injury ·ELECTRO MEDICAL SYSTEMS SA·Product code FFK·January 20, 2025

    AIR-FLOW PERIO POWDER

    FDA Adverse Event
    Other ·E.M.S. ELECTRO MEDICAL SYSTEMS SA·Product code EFB·June 25, 2013

    AIR-FLOW POWDER PERIO

    FDA Adverse Event
    Other ·E.M.S. ELECTRO MEDICAL SYSTEMS SA·Product code EFB·November 16, 2012

    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

    Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort 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: 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 Recall
    Open, Classified ·Electro Medical Systems SA Chemin De La Vuarpilliere·Product code ELC·March 13, 2024

    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 Recall
    Open, Classified ·Electro Medical Systems SA Chemin De La Vuarpilliere·Product code ELC·March 13, 2024

    Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE

    FDA Recall
    Open, Classified ·Electro Medical Systems SA Chemin De La Vuarpilliere·Product code ELC·March 13, 2024

    LithoClast Foot Pedal, reference EK-166 Catalog Number: 840-703 Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No 840-700.. Manufactured by EMS Electro Medical Systems S, Nyon, Switzerland. Distributed by Boston Scientifc/Microvasive,Natick, MA

    FDA Recall
    Terminated ·Electro Medical Systems (EMS SA) Rte de Champ-Colin·Product code FFK·October 3, 2003

    Swiss Lithocast Ultra Ultrasound Handpiece (EMS- PN:EL-236) used in combination with Swiss Lithoclast Ultra System .

    FDA Recall
    Terminated ·E.M.S. Electro Medical Systems SA Chemin de la Vuarpilliere 31 Nyon, Vaud Switzerland·Product code FFK·March 16, 2005

    Planmeca Oy

    Importer
    🇫🇮 Finland·8 Manufacturers

    Emergo Europe B.V.

    Authorized representative
    🇳🇱 Netherlands·900 Manufacturers·22100 Devices

    Plandent Oy

    Importer
    🇫🇮 Finland·43 Manufacturers

    Arseus Medical Group nv

    Importer
    🇧🇪 Belgium·69 Manufacturers

    AIR-FLOW

    FDA UDI
    E.M.S. Electro Medical Systems S.A.·07613353258061·AIRFLOW One

    Piezon

    FDA UDI
    E.M.S. Electro Medical Systems S.A.·07613353317447·PIEZON® NO PAIN Built in kit 24-32V DC / 24V AC...