BEUDAMED
    90 results · 107ms · Sources: EU EUDAMED, US FDA

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    THE STANDARD CO., LTD.

    FDA registration
    THE STANDARD CO., LTD.·6 products·🇰🇷 South Korea

    Black Eye

    FDA UDI
    THE STANDARD CO.,LTD.·08809380059002·

    Blue Eye

    FDA UDI
    THE STANDARD CO.,LTD.·08809380050207·

    Blue Eye

    FDA UDI
    THE STANDARD CO.,LTD.·08809380057473·

    CMC VASCULAR ACCESS PACK

    FDA Adverse Event
    Malfunction ·DEROYAL INDUSTRIES, INC.·Product code LRO·July 25, 2023

    GC-3PLY-ISO 3 PLY DISPOSABLE MASK

    FDA Adverse Event
    Malfunction ·NINGBO YIXIN INTELLIGENTIZED SCIENCE AND TECHNOLOGY·Product code LYU·August 20, 2020

    FOLEY CATHETER, 2W STD SEC CH16

    FDA Adverse Event
    Malfunction ·UNOMEDICAL SDN BHD·Product code KOD·January 24, 2013

    FOLEY CATHETER, 2W STD SEC CH14

    FDA Adverse Event
    Malfunction ·UNOMEDICAL SDN BHD·Product code KOD·January 24, 2013

    EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code ODG·June 28, 2021

    FOLEY CATHETER, 2W STD SEC CH14

    FDA Adverse Event
    Malfunction ·UNOMEDICAL SDN BHD·Product code KOD·January 24, 2013

    TRACHEAL INTUBATION FIBERSCOPE

    FDA Adverse Event
    Malfunction ·Product code EOQ·August 2, 2021

    AURA CUSHION

    FDA Adverse Event
    Injury ·ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB·Product code FNM·February 15, 2017

    FLOWTRON ACS 900

    FDA Adverse Event
    Injury ·GETINGE (SUZHOU) CO., LTD.·Product code JOW·January 5, 2017

    XTRA TRAC SHOEC, XLG

    FDA Adverse Event
    Malfunction ·O&M HALYARD, INC.·Product code FXP·October 17, 2024

    ZIMMON BILIARY STENT

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

    GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser Light Show (LLS)projectors for the purposes of demonstration and entertainment.

    FDA Enforcement
    Class II ·Ongoing·GAGA PRO LIGHTING EQUIPMENT CO.,·April 5, 2023

    Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z Illuminations Galaxy Laser projectors that emit various colors and light patterns for entertainment and decorative purposes.

    FDA Enforcement
    Class II ·Terminated·SANTA JOY ORNAMENT & GIFTWARE CO·June 13, 2018

    TICON 55 UVB

    FDA Adverse Event
    Injury ·ST. SHINE OPTICAL GROUP CO.·Product code LPL·March 3, 2005

    ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

    FDA Adverse Event
    Malfunction ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code GCJ·January 25, 2021

    Osstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.

    FDA Enforcement
    Class II ·Ongoing·OSSTEM Implant Co., Ltd.·November 12, 2025