BEUDAMED
    20 results · 46ms · Sources: EU EUDAMED, US FDA

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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

    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 Recall
    Terminated ·US Endoscopy Group Inc·Product code KOG·December 22, 2011

    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 Recall
    Terminated ·US Endoscopy Group Inc·Product code OCX·March 7, 2013

    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 Recall
    Terminated ·US Endoscopy Group Inc·Product code PKL·February 4, 2019

    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 Recall
    Terminated ·US Endoscopy Group Inc·Product code FBK·May 18, 2016

    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 Recall
    Terminated ·US Endoscopy Group Inc·Product code KOG·October 31, 2014

    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 Recall
    Terminated ·US Endoscopy Group Inc·Product code FGO·November 14, 2011

    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 Recall
    Terminated ·US Endoscopy Group Inc·Product code OCZ·March 10, 2015

    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 Recall
    Terminated ·US Endoscopy Group Inc·Product code OCX·February 17, 2015

    Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect and transect tissue during gastrointestinal endoscopic procedures.

    FDA Recall
    Terminated ·US Endoscopy Group Inc·Product code FDI·July 14, 2015

    Roth Net Polyp Retrieval

    FDA Recall
    Terminated ·US Endoscopy Group Inc·Product code GCJ·December 13, 2016

    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