14 results · 9ms · Sources: EU EUDAMED, US FDA

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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

Visera Hysterovideoscope Olympus HYF Type V

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·September 6, 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

Olympus CYSTONEPHROFIBERSCOPE Model: CYF-5

FDA Enforcement
Class II ·Ongoing·Olympus Corporation of the Americas·June 22, 2022

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

BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-635; cavity varnish

FDA Enforcement
Class II ·Ongoing·Young Dental Manufacturing I, LLC·June 14, 2023

Model No. CYF-V2, VISERA Cysto-Nephro Videoscope

FDA Enforcement
Class II ·Ongoing·Shirakawa Olympus Co., Ltd.·January 17, 2024

Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18F Sodium Fluoride (NaF) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (PET Positron Emission Tomography - nuclear medicine) diagnostic procedures.

FDA Enforcement
Class II ·Ongoing·Bayer Medical Care, Inc.·January 18, 2023