BEUDAMED
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    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

    Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.

    FDA Recall
    Open, Classified ·Dental EZ Group Star Dental Division·Product code ELC·May 30, 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

    GentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02

    FDA Recall
    Open, Classified ·Sonendo Inc·Product code ELC·October 14, 2022

    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

    GentleWave System Posterior CleanFlow Procedure Instrument with Matrices (Single) REF GW-PST-PI01

    FDA Recall
    Open, Classified ·Sonendo Inc·Product code ELC·October 14, 2022

    Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.

    FDA Recall
    Open, Classified ·Dental EZ Group Star Dental Division·Product code ELC·May 30, 2024

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Recall
    Open, Classified ·Biointellisense Inc. 570 El Camino Real·Product code DRG·July 19, 2024

    Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant

    FDA Recall
    Open, Classified ·MED-EL Elektromedizinische Gereate, Gmbh Furstenweg 77a Innsbruck Austria·Product code MCM·April 18, 2024