11 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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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
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
FDA Recall
Open, Classified
·Advance Medical Designs, Inc.·Product code GDF·July 7, 2023
procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-GG023, b) 28-GG105, c) 28-GG107, d) 28-GG121, e) 28-GG219, f) 28-GG223, g) 28-GG303, h) 28-GG307, i) 28-GG519, j) 28-GG519PC, k) 28-GG521, l) 28-GG521PC, m) 28-GG529, n) 28-GG553, o) 28-GG569, p) 28-GG571, q) 28-GG723
FDA Recall
Open, Classified
·Advance Medical Designs, Inc.·Product code GDF·July 7, 2023
Injection Needle, REF: 25207
FDA Recall
Open, Classified
·Karl Storz Endoscopy·Product code GCF·October 24, 2023
ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
FDA Recall
Open, Classified
·Sklar Instruments·Product code GAF·December 3, 2024