10 results
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62ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cytological cell samples in the gastrointestinal tract.
FDA Enforcement
Class II
·Terminated·US Endoscopy Group Inc·September 26, 2012
UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. Used to cover the opening to the biopsy/suction channel of an endoscope.
FDA Enforcement
Class II
·Terminated·US Endoscopy Group Inc·December 31, 2014
Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable Velocity biopsy valve is used to cover the opening of the biopsy inlet port of a flexible gastrointestinal endoscope. The Velocity biopsy valve provides access for endoscopic device passage and exchange, helps maintain insufflation, and minimizes leakage of biomaterial from the accessory port throughout the gastrointestinal endoscopic procedure. The Velocity biopsy valve provides a connection for irrigation through the Velocity irrigation pump.
FDA Enforcement
Class II
·Terminated·US Endoscopy Group Inc·July 8, 2015
Torrent" irrigation tubing. Product Usage: The Torrent irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
FDA Enforcement
Class II
·Terminated·US Endoscopy Group Inc·April 17, 2013
Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
FDA Enforcement
Class II
·Terminated·US Endoscopy Group Inc·October 10, 2012
Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.
FDA Enforcement
Class II
·Terminated·US Endoscopy Group Inc·October 7, 2015
Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.
FDA Enforcement
Class II
·Terminated·US Endoscopy Group Inc·April 22, 2015
Roth Net Polyp Retrieval
FDA Enforcement
Class III
·Terminated·US Endoscopy Group Inc·March 15, 2017
Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible sheath device intended to be used for the injection of various types of media through flexible endoscopes
FDA Enforcement
Class II
·Terminated·US Endoscopy Group Inc·October 26, 2016
US Endoscopy Padlock Clip defect closure system Ref: C910001 The Padlock Clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.
FDA Enforcement
Class II
·Terminated·US Endoscopy Group Inc·March 20, 2019