16 results
·
15ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
×
Orascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1 pk. and 20 pk.
FDA Recall
Open, Classified
·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025
Orascoptic Superior Visualization Custom loupes configured with Phantom Frames
FDA Recall
Open, Classified
·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025
Orascoptic Superior Visualization Phantom Essential kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
FDA Recall
Open, Classified
·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025
Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad, a screw, lens cleaning wipe, side shields, head strap, and a screwdriver)
FDA Recall
Open, Classified
·Orascoptic Surgical Acuity·Product code EBA·July 3, 2025
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
abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Medium REF BC21089
FDA Recall
Open, Classified
·S & MOHR AMERICA, S.A. DE C.V. Circuito De La Industria Poniente Lote 10 C Estado De Mexico Mexico·Product code CAH·January 5, 2023
AlternatiV+ Screw-In Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025
Fixone Hybrid Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025
Genesis Screw-In Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025
Genesis Dual Thread Screw-In Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025
AlternatiV+ Max Knotless Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025
Fixone Biocomposite Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025
Genesis Push-In Suture Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025
Genesis Knotless Anchor
FDA Recall
Open, Classified
·Aju Pharm Co., Ltd.
Room 201, Room 207, Bl A
Bundangtekeunopakeu; 697 Pangyo-Ro; Bundang
Seongnam Korea (the Republic of)·Product code MAI·December 17, 2025