62 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Country: Japan
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CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Visera Hysterovideoscope Olympus HYF Type V
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
JAPAN OPTICAL CO.,LTD.
Manufacturer
🇯🇵 Japan
OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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
Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VH, CYF-VHR.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
FDA Enforcement
Class II
·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023
Model No. CYF-5, Cystonephrofiberscope
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Model No. CYF-5R, Cystonephrofiberscope
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Model No. CYF-VHR, CYSTO-NEPHRO VIDEOSCOPE
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Model No. CYF-V2R, VISERA Cysto-Nephro Videoscope
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
FDA Enforcement
Class II
·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024
BM Test HbA1c Diluent
Device
EU IVDD
·
Eu Ivd General
·JEOL Ltd. MF·On the market
BM Test HbA1c Control
Device
EU IVDD
·
Eu Ivd General
·JEOL Ltd. MF·On the market
BM Test HbA1c Calibrator
Device
EU IVDD
·
Eu Ivd General
·JEOL Ltd. MF·On the market
BM Test HbA1c Reagent 1
Device
EU IVDD
·
Eu Ivd General
·JEOL Ltd. MF·On the market
BM Test HbA1c Reagent 2
Device
EU IVDD
·
Eu Ivd General
·JEOL Ltd. MF·On the market