BEUDAMED
    26 results · 62ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    JAPAN OPTICAL CO.,LTD.

    Manufacturer
    🇯🇵 Japan

    JAPAN OPTICAL CO., LTD.

    FDA registration
    JAPAN OPTICAL CO., LTD.·3 products·🇯🇵 Japan

    EVIS LUCERA ELITE DUODENOVIDEOSCOPE

    FDA Adverse Event
    Injury ·AIZU OLYMPUS CO., LTD.·Product code FDT·December 12, 2023

    BIOPSY FORCEPS

    FDA Adverse Event
    Injury ·AOMORI OLYMPUS CO., LTD.·Product code FCL·December 12, 2023

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    FDA Adverse Event
    Injury ·AOMORI OLYMPUS CO., LTD.·Product code KNS·December 12, 2023

    EVIS LUCERA DUODENOVIDEOSCOPE

    FDA Adverse Event
    Injury ·AIZU OLYMPUS CO., LTD.·Product code FDT·December 11, 2023

    EVIS DUODENOVIDEOSCOPE

    FDA Adverse Event
    Injury ·AIZU OLYMPUS CO., LTD.·Product code FDT·December 12, 2023

    ZILVER 635 BILIARY SELF EXPANDING METAL STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·December 6, 2024

    ZIMMON BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·April 9, 2024

    RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by NIDEK CO., Ltd., Aichi, Japan. Instrument provides means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subject's eyes for purpose of determining refractive error and binocular functions.

    FDA Enforcement
    Class II ·Terminated·Nidek Inc·July 2, 2014

    ZIMMON PANCREATIC STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·October 2, 2020

    ZIMMON BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·June 1, 2022

    ZIMMON BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·May 31, 2022

    SINGLE USE 3-LUMEN SPHINCTEROTOME V

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code KNS·November 5, 2020

    SONOSURG SHORT HOOK 5MM O.D.

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code LFL·November 29, 2021

    COTTON-LEUNG BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·July 22, 2022

    ELECTROSURGICAL KNIFE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code KGE·March 2, 2022

    EVIS LUCERA XENON LIGHT SOURCE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GCT·March 2, 2022

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDS·March 2, 2022

    EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDS·March 2, 2022