BEUDAMED
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    GREEN LASER PHOTOCOAGULATOR SYSTEM

    FDA UDI
    NIDEK CO.,LTD.·04987669100202·The GREEN LASER PHOTOCOAGULATOR SYSTEM GYC-1000...

    Green Laser Photocoagulator

    FDA UDI
    NIDEK CO.,LTD.·04987669100851·The NIDEK Green Laser Photocoagulator GYC-500 i...

    USA Series

    FDA UDI
    Gyrus ACMI, LLC·00821925002517·USA Series Continuous Flow Outer Sheath 7 mm

    NIDEK MODEL GYC-1500 AND GYC-2000

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    GYC-1000

    FDA Adverse Event
    Malfunction ·NIDEK INCORPORATED·Product code HQF·February 8, 2017

    GYC-1000

    FDA Adverse Event
    Malfunction ·Product code HQF·September 1, 2021

    Green Laser Photocoagulator GYC-500

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    NIDEK PRIMA MODEL GYC-1500/2000

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    GYC-1000

    FDA Adverse Event
    Malfunction ·NIDEK CO. LTD.·Product code HQF·February 14, 2019

    GYC-1000

    FDA Adverse Event
    Malfunction ·NIDEK CO., LTD.·Product code HQF·February 4, 2016

    YC-1800

    FDA Adverse Event
    Malfunction ·NIDEK CO, LTD·Product code HQF·August 22, 2016

    GYC-1000

    FDA Adverse Event
    Malfunction ·NIDEK. CO. LTD.·Product code HQF·March 8, 2019

    GYC-1000

    FDA Adverse Event
    Malfunction ·NIDEK CO., LTD.·Product code HQF·March 8, 2016

    GYC-1000

    FDA Adverse Event
    Injury ·NIDEK CO, LTD.·Product code HQF·August 29, 2016

    GYC-500D

    FDA Adverse Event
    Malfunction ·NIDEK INC.·Product code HQF·May 31, 2018

    GYC-1000

    FDA Adverse Event
    Malfunction ·NIDEK CO., LTD.·Product code HQF·June 18, 2015

    NIDEK PRIMA KTP LASER SYSTEM

    FDA Adverse Event
    Injury ·NIDEK CO. LTD.·Product code GEX·March 28, 2000

    Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

    FDA Recall
    Terminated ·Nidek Inc·Product code GEX·March 25, 2015

    Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP-01 0W02 and GYC4EP-1 0Z20; The Nidek Green Laser Photocoagulator Model GYC- 1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.

    FDA Recall
    Terminated ·Nidek Inc·Product code GEX·March 25, 2015