759 results
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17ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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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 Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·September 25, 2023
EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDS·October 31, 2024
EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDS·April 22, 2022
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 Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDS·September 18, 2024
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·October 16, 2023
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·October 16, 2023
Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FET·August 21, 2024
Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope
FDA Recall
Terminated
·Integrated Medical Systems Inc·Product code GCQ·January 20, 2016
Olympus GIF-H180J Gastrointestinal Videoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
FDA Recall
Terminated
·Olympus Corporation of the Americas·Product code NWB·December 17, 2018
COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code GIF·April 13, 2015
Hematology Diluent M-53D used with BC-5390 Hematology Analyzer; Part Number: 105-007867-00 (20L container) The M-53D diluent is an azide-free, filtered isotonic solution for counting and sizing blood cells. It is for use with the Mindray BC-5390 Hematology Analyzer.
FDA Recall
Terminated
·Mindray DS USA, Inc. dba Mindray North America·Product code GIF·January 24, 2018
COULTER DxH Diluent, REF 628017; diluent used for counting and sizing blood cells
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code GIF·May 31, 2023