Aizu Olympus Co., Ltd.

FDA Regulatory Profile

Summary

Total Recalls
31
510(k) Clearances
1
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0873-2026Class IIOlympus OER-ProOctober 31, 2025
Z-0872-2026Class IIOlympus OER-EliteOctober 31, 2025
Z-0874-2026Class IIOlympus OER-MiniOctober 31, 2025
Z-0417-2024Class IIGIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPEOctober 16, 2023
Z-0418-2024Class IIPCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPEOctober 16, 2023
Z-0415-2024Class IICF-HQ190L EVIS EXERA III COLONOVIDEOSCOPEOctober 16, 2023
Z-0416-2024Class IIGIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPEOctober 16, 2023
Z-0419-2024Class IIPCF-H190L, EVIS EXERA III COLONOVIDEOSCOPEOctober 16, 2023
Z-0333-2024Class IIGastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgeSeptember 25, 2023
Z-0339-2024Class IITracheal videoscope- For airway management, which includes observation to access airway anatomy, endSeptember 25, 2023
Z-0344-2024Class IITransnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach.September 25, 2023
Z-0334-2024Class IIGastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophaSeptember 25, 2023
Z-0345-2024Class IIUltrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and othSeptember 25, 2023
Z-0335-2024Class IIHysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.September 25, 2023
Z-0330-2024Class IIICholeodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.September 25, 2023
Z-0331-2024Class IICystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model NSeptember 25, 2023
Z-0337-2024Class IIHysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.September 25, 2023
Z-0343-2024Class IISmall intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (iSeptember 25, 2023
Z-0336-2024Class IIHysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.September 25, 2023
Z-0341-2024Class IIColonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid September 25, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K043487EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1January 28, 2005