15 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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
Alcohol (ALC) Test Saliva
FDA Recall
Open, Classified
·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DIC·November 3, 2025
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Light); c) 4068140 (Pendant Surgical Light); d) 4068210 (Ceiling Duo Surgical Lights); e) 4068310 (Ceiling Trio Surgical Lights); f) 4068410 (Ceiling Quad Surgical Lights)
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FTD·June 4, 2024
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b) 4028210 (Ceiling Duo Surgical Lights); c) 4028310 (Ceiling Trio Surgical Lights)
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code KQM·June 4, 2024
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FTD·June 4, 2024
Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
FDA Recall
Open, Classified
·Dutch Ophthalmic USA, Inc.·Product code HQF·April 14, 2021
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a medical device that detects the presence of the SmartClip Soft Tissue Marker(s) and provides real-time three-dimensional navigation during surgery.
FDA Recall
Open, Classified
·Elucent Medical Inc·Product code NEU·November 18, 2024
The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as verifying the length of the Drill Stops via a ruler and depth markings. The Drill Stop Kit also allows for optional storage of some DLC drills. Drill Stops: The Drill Stop is a reusable (up to 30 osteotomies) hollow cylinder with retention prongs that clips onto the hub of the DLC drill, creating a stop function at the desired predetermined drill depth (6mm, 8mm, 10mm, 11.5mm, 13mm and 16mm). The Drill Stops come in two formats (Short 6-13mm depth, and Long 6-16mm depth), and in several diameters for different diameter drills.
FDA Recall
Open, Classified
·Implant Direct Sybron Manufacturing LLC·Product code KCT·May 1, 2025
STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,
FDA Recall
Open, Classified
·Stradis Medical, LLC dba Stradis Healthcare·Product code EIC·November 2, 2022