BEUDAMED
    9 results · 8ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii × Status: Terminated × Clear all

    Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·March 20, 2019

    Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope

    FDA Enforcement
    Class II ·Terminated·Integrated Medical Systems Inc·March 2, 2016

    InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.

    FDA Enforcement
    Class II ·Terminated·Steris Corporation·August 5, 2020

    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