Nidek recalls
Nidek appears in 21 official U.S. recall notices indexed by RecallRadar, most recently on 2020-01-08.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium e…
FDA Device · Class III · 2020-01-08 · Nidek - RT-5100 Refractor, a component of the Epic-5100 System
FDA Device · Class III · 2018-12-26 · Nidek - AUTO REF/KERATOMETER ARK-1s
FDA Device · Class II · 2018-04-18 · Nidek - Final Fit Software Version 1.11 and 1.12
FDA Device · Class II · 2017-03-29 · Nidek - SPECULAR MICROSCOPE CEM-530
FDA Device · Class II · 2016-09-07 · Nidek - OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier
FDA Device · Class II · 2016-08-24 · Nidek - RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing means of positioning spherical and cylindrical len…
FDA Device · Class II · 2016-03-30 · Nidek - 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 1.07.0…
FDA Device · Class II · 2015-09-02 · Nidek - Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Green Laser Photocoagulator Model GYC- 1000 is indic…
FDA Device · Class II · 2015-07-22 · Nidek - Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System
FDA Device · Class II · 2015-07-22 · Nidek - EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest
FDA Device · Class II · 2015-06-10 · Nidek - YC-1800 OPHTHALMIC YAG LASER SYSTEM
FDA Device · Class II · 2015-04-08 · Nidek - MC-500 Multicolor Laser Photocoagulator
FDA Device · Class II · 2015-02-25 · Nidek - MC-500 Multicolor Laser Photocoagulator using software version 2.20
FDA Device · Class II · 2014-11-26 · Nidek - Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20
FDA Device · Class II · 2014-11-26 · Nidek - Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device
FDA Device · Class II · 2014-11-26 · Nidek - GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgic…
FDA Device · Class II · 2014-08-20 · Nidek - MC-500 Multicolor Laser Photocoagulator
FDA Device · Class II · 2014-08-06 · Nidek - Non-Mydriatic Auto Fundus Camera
FDA Device · Class II · 2014-07-09 · Nidek - RT-5100 Refractor and RT-3100 Refractor
FDA Device · Class II · 2014-07-02 · Nidek - 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…
FDA Device · Class II · 2013-09-04 · Nidek