18 results
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19ms
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Sources: EU EUDAMED, US FDA
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Country: Japan
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Visera Hysterovideoscope Olympus HYF Type V
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
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
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
VIVA (HBF-222T-EBK)
Device
EU MDR
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Eu Md Class 1
·OMRON Healthcare Co., Ltd.·On the market·22 countries
BF212 (HBF-212-EW)
Device
EU MDR
·
Eu Md Class 1
·OMRON Healthcare Co., Ltd.·On the market·14 countries
BF214 (HBF-214-EBW)
Device
EU MDR
·
Eu Md Class 1
·OMRON Healthcare Co., Ltd.·On the market·16 countries
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
Body Comp Monitor BF511 Turq (HBF-511T-E)
Device
EU MDR
·
Eu Md Class 1
·OMRON Healthcare Co., Ltd.·On the market·20 countries
Body Comp Monitor BF511 Blue (HBF-511B-E)
Device
EU MDR
·
Eu Md Class 1
·OMRON Healthcare Co., Ltd.·On the market·28 countries
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
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