50 results
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6ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model Numbers: GIF-1TH190, GIF-1TQ160, GIF-2T160, GIF-2TH180, GIF-H170, GIF-H180, GIF-H180J, GIF-H190, GIF-HQ190, GIF-LV1, GIF-N180, GIF-Q150, GIF-Q160Z, GIF-Q180, GIF-XP180N, GIF-XP190N, GIF-XTQ160. 510(k) Numbers: K112680, K954451, K051645, K100584, K111756, K011151, K123317.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·December 11, 2024
Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number: GIF-1TH190 Software Version: N/A Product Description: This instrument is intended to be used with an Olympus video system center, light source, documentation equipment, monitor, EndoTherapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery.
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 27, 2024
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·June 29, 2022
EVIS EXERA III Gastrointestinal Videoscope
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·November 15, 2023
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
FDA Enforcement
Class II
·Ongoing·Olympus Corporation of the Americas·October 30, 2024
Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope
FDA Enforcement
Class II
·Terminated·Integrated Medical Systems Inc·March 2, 2016
Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
FDA Enforcement
Class II
·Terminated·Olympus Corporation of the Americas·March 20, 2019
Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021
Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, and other accessories.
FDA Enforcement
Class II
·Terminated·Respironics California, LLC·February 3, 2021