BEUDAMED
    15 results · 7ms · Sources: EU EUDAMED, US FDA

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    Filters FDA Enforcement × Classification: Class Ii × Clear all

    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

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

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

    Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens

    FDA Enforcement
    Class II ·Terminated·Medtronic·December 28, 2016

    ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, SKU: a) F00573301020A b) F00573301026X c) F00573301009B Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and menstrual pain. ThermaCare HeatWraps are made up of heat cells enclosed within wraps that consists of a mixture of ingredients including soft iron, carbon or absorbent gelling material and brine solution (water, salt, and sodium thiosulphate). The heat cells get activated in the presence of air (oxygen) to produce a low-level heat.

    FDA Enforcement
    Class II ·Terminated·PF Consumer Healthcare 1 LLC·June 5, 2019

    ThermaCare HEATWRAPS, ADVANCED BACK PAIN THERAPY, UPC 305733010037 - Product Usage: ThermaCare(R) HeatWraps are indicated in adults to provide heat therapy for the temporary relief of minor muscular and joint pains associated with overexertion, strains, sprains, and arthritis and menstrual pain. ThermaCare HeatWraps are made up of heat cells enclosed within wraps that consists of a mixture of ingredients including soft iron, carbon or absorbent gelling material and brine solution (water, salt, and sodium thiosulphate). The heat cells get activated in the presence of air (oxygen) to produce a low-level heat.

    FDA Enforcement
    Class II ·Terminated·PF Consumer Healthcare 1 LLC·June 5, 2019