14 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
FDA Recall
Open, Classified
·Merit Medical Systems, Inc.·Product code DRE·August 12, 2024
Colonoscope, Model Number PCF-H190L.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDF·January 11, 2024
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
Colonoscope, Model Number CF-HQ190L.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDF·January 11, 2024
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDF·September 14, 2023
EVIS EXERA III Gastrointestinal Videoscope
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDF·October 2, 2023
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·October 16, 2023
Colonoscope, Model Number CF-HQ190I.
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FDF·January 11, 2024
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
FDA Recall
Open, Classified
·Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan·Product code FDF·October 16, 2023
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
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
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
Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10; Gastroscope Family # 2- Gastroscopes with a Water Jet Channel Models: EG-2990i, EG-2990K, EG-3490K, EG29-i10; Gastroscope Family # 3-Gastroscopes with Two Instrument Channels and a Water Jet Channel Models: EG-3890TK
FDA Recall
Open, Classified
·Pentax of America Inc·Product code FDF·July 14, 2021
Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK
FDA Recall
Open, Classified
·Pentax of America Inc·Product code FDF·July 14, 2021