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

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    Filters Classification: Class Ii ×

    Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve). Model Numbers: PCF-H180AI, PCF-H180AL, PCF-H190DI, PCF-H190DL, PCF-H190I, PCF-H190L, PCF-H190TI, PCF-H190TL, PCF-HQ190I, PCF-HQ190L, PCF-PH190I, PCF-PH190L, PCF-Q180AI, PCF-Q180AL, PCF-S.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Colonoscope, Model Number PCF-H190TL.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 2024

    Colonoscope, Model Number PCF-Q180AL.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 2024

    Colonoscope, Model Number PCF-H180AL.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 2024

    Colonoscope, Model Number PCF-HQ190L.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 2024

    Colonoscope, Model Number PCF-H190L.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 2024

    Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum and sigmoid colon). Model Number: PCF-S.

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·November 29, 2023

    Colonoscope, Model Number PCF-H190DL.

    FDA Enforcement
    Class II ·Ongoing·Olympus Corporation of the Americas·March 6, 2024

    PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023

    PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE

    FDA Enforcement
    Class II ·Ongoing·Aizu Olympus Co., Ltd.·December 6, 2023

    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

    CombiDiagnost PCF, Software v. 1.0.5, Product Code 709030 - Product Usage: Xray system, diagnostic, fluoroscopic, general purpose.

    FDA Enforcement
    Class II ·Ongoing·Philips Medical Systems Gmbh, DMC·February 26, 2020

    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