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Aizu Olympus Co., Ltd.

30 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Olympus OER-Elite recall (Z-0872-2026)Aizu Olympus Co., Ltd.2025-12-02
Olympus OER-Pro recall (Z-0873-2026)Aizu Olympus Co., Ltd.2025-12-02
Olympus OER-Mini recall (Z-0874-2026)Aizu Olympus Co., Ltd.2025-12-02
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE recall (Z-0415-2024)Aizu Olympus Co., Ltd.2023-11-29
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE recall (Z-0416-2024)Aizu Olympus Co., Ltd.2023-11-29
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE recall (Z-0417-2024)Aizu Olympus Co., Ltd.2023-11-29
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE recall (Z-0418-2024)Aizu Olympus Co., Ltd.2023-11-29
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE recall (Z-0419-2024)Aizu Olympus Co., Ltd.2023-11-29
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial recall (Z-0327-2024)Aizu Olympus Co., Ltd.2023-11-17
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided need recall (Z-0328-2024)Aizu Olympus Co., Ltd.2023-11-17
Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (includ recall (Z-0329-2024)Aizu Olympus Co., Ltd.2023-11-17
Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. recall (Z-0330-2024)Aizu Olympus Co., Ltd.2023-11-17
Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidne recall (Z-0331-2024)Aizu Olympus Co., Ltd.2023-11-17
Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airwa recall (Z-0332-2024)Aizu Olympus Co., Ltd.2023-11-17
Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endosc recall (Z-0333-2024)Aizu Olympus Co., Ltd.2023-11-17
Gastrointestinal videoscope-indicated for use within the upper digestive tract (including recall (Z-0334-2024)Aizu Olympus Co., Ltd.2023-11-17
Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T. recall (Z-0335-2024)Aizu Olympus Co., Ltd.2023-11-17
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V. recall (Z-0336-2024)Aizu Olympus Co., Ltd.2023-11-17
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP. recall (Z-0337-2024)Aizu Olympus Co., Ltd.2023-11-17
Tracheal fiberscope-airway management, which includes observation to access airway anatomy recall (Z-0338-2024)Aizu Olympus Co., Ltd.2023-11-17
Tracheal videoscope- For airway management, which includes observation to access airway an recall (Z-0339-2024)Aizu Olympus Co., Ltd.2023-11-17
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endob recall (Z-0340-2024)Aizu Olympus Co., Ltd.2023-11-17
Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum recall (Z-0341-2024)Aizu Olympus Co., Ltd.2023-11-17
Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract recall (Z-0342-2024)Aizu Olympus Co., Ltd.2023-11-17
Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestiv recall (Z-0343-2024)Aizu Olympus Co., Ltd.2023-11-17
Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus an recall (Z-0344-2024)Aizu Olympus Co., Ltd.2023-11-17
Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspirati recall (Z-0345-2024)Aizu Olympus Co., Ltd.2023-11-17
Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary recall (Z-0346-2024)Aizu Olympus Co., Ltd.2023-11-17
Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliar recall (Z-0347-2024)Aizu Olympus Co., Ltd.2023-11-17
Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidne recall (Z-0348-2024)Aizu Olympus Co., Ltd.2023-11-17

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