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    MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.

    FDA Recall
    Terminated ·Nidek Inc·Product code HQF·June 9, 2014

    Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing images of the retina and anterior segment of the eye. Distributed by Nidek, Inc, and Marco Opthalmic Inc. Manufactured by Nidek Co. Ltd, Japan.

    FDA Recall
    Terminated ·Nidek Inc·Product code HKI·June 16, 2014

    OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.

    FDA Recall
    Terminated ·Nidek Inc·Product code HJO·July 1, 2016

    NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.

    FDA Recall
    Terminated ·Nidek Medical Products Inc·Product code CAW·May 1, 2012

    NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.

    FDA Recall
    Terminated ·Nidek Medical Products Inc·Product code CAW·May 1, 2012

    NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.

    FDA Recall
    Terminated ·Nidek Medical Products Inc·Product code CAW·May 1, 2012

    NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.

    FDA Recall
    Terminated ·Nidek Medical Products Inc·Product code CAW·May 1, 2012

    NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.

    FDA Recall
    Terminated ·Nidek Medical Products Inc·Product code CAW·May 1, 2012

    NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.

    FDA Recall
    Terminated ·Nidek Medical Products Inc·Product code CAW·May 1, 2012

    NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.

    FDA Recall
    Terminated ·Nidek Medical Products Inc·Product code CAW·May 1, 2012

    NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.

    FDA Recall
    Terminated ·Nidek Medical Products Inc·Product code CAW·May 1, 2012

    NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.

    FDA Recall
    Terminated ·Nidek Medical Products Inc·Product code CAW·May 1, 2012

    OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis.

    FDA Recall
    Terminated ·Nidek Inc·Product code HKO·June 15, 2015

    RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects eye for purpose of determining refractive error and binocular functions.

    FDA Recall
    Terminated ·Nidek Inc·Product code HKN·February 29, 2016

    Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.

    FDA Recall
    Terminated ·Nidek Inc·Product code HQF·October 24, 2012

    AUTO REF/KERATOMETER ARK-1s

    FDA Recall
    Terminated ·Nidek Inc.·Product code HKO·December 20, 2017

    GYC-1000 Green Laser Photocoagulator system 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·May 16, 2014

    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

    Final Fit Software Version 1.11 and 1.12; PC Based software installed outside Nidek EC-5000 Excimer Laser System. Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.

    FDA Recall
    Terminated ·Nidek Inc·Product code LZS·February 1, 2017

    NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX is indicated for use as file management software for ophthalmic images.

    FDA Recall
    Terminated ·Nidek Inc·Product code HKI·August 1, 2013