BEUDAMED
    7 results · 22ms · Sources: EU EUDAMED, US FDA

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    Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    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

    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

    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

    ARTERIOVENOUS FISTULA NEEDLES

    Device
    EU MDD · Eu Md Class 2a ·SB-KAWASUMI LABORATORIES, INC.·On the market·5 countries

    EYEVAN

    Device
    EU MDR · Eu Md Class 1 ·EYEVAN Inc.·On the market