31 results
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59ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Olympus OER-Elite
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 10, 2025
Olympus OER-Pro
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 10, 2025
Olympus OER-Mini
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 10, 2025
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
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
EVIS EXERA III Bronchovideoscope
FDA Enforcement
Class II
·Terminated·Aizu Olympus Co., Ltd.·August 31, 2022
Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery Model Numbers: TJF-145, TJF-150, TJF-Q180V, TJF-Q190V.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, URF-P7R, URF-V2, URF-V2R, URF-V3, URF-V3R.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: LF-DP, LF-GP, LF-TP.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct). Model Numbers: URF-P6, URF-P6R.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model Numbers: BF-UC180F, BF-UC190F.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023