9 results
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52ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.
FDA Enforcement
Class II
·Ongoing·Northgate Technologies, Inc.·December 15, 2021
AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
FDA Enforcement
Class II
·Terminated·Northgate Technologies, Inc.·June 15, 2022
Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures
FDA Enforcement
Class II
·Terminated·Northgate Technologies, Inc.·December 28, 2016
Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.
FDA Enforcement
Class II
·Terminated·Northgate Technologies, Inc.·November 15, 2017
Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
FDA Enforcement
Class II
·Terminated·Northgate Technologies, Inc.·May 13, 2020
AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
FDA Enforcement
Class II
·Terminated·Northgate Technologies, Inc.·May 13, 2020
ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.
FDA Enforcement
Class II
·Terminated·Northgate Technologies, Inc.·May 13, 2020
ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery).
FDA Enforcement
Class II
·Terminated·Northgate Technologies, Inc.·March 3, 2021
Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.
FDA Enforcement
Class II
·Terminated·Northgate Technologies, Inc.·March 3, 2021