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AIZU OLYMPUS CO., LTD.

FDA registration
AIZU OLYMPUS CO., LTD.·28 products·🇯🇵 Japan

EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

FDA Adverse Event
Malfunction ·SHIRAKAWA OLYMPUS CO., LTD·Product code ODG·November 28, 2022

EVIS LUCERA ELITE BRONCHOVIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code EOQ·November 16, 2023

3D VISUALIZATION UNIT

FDA Adverse Event
Malfunction ·SHIRAKAWA OLYMPUS CO., LTD·Product code FET·August 4, 2022

EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDS·June 16, 2025

EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDS·June 16, 2025

UNKNOWN

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FDS·November 14, 2023

URETERO-RENO FIBERSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FGB·January 13, 2022

URETERO-RENO FIBERSCOPE

FDA Adverse Event
Malfunction ·AIZU OLYMPUS CO., LTD.·Product code FGB·February 1, 2022

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