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Nidek Inc

16 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular recall (Z-2711-2016)Nidek Inc2016-09-01
RT-5100 (Epic 5100) Refractor and RT 3100 Refractor: Product Usage: Instrument providing m recall (Z-1245-2016)Nidek Inc2016-03-24
OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 recall (Z-2477-2015)Nidek Inc2015-08-27
Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1: The Nidek Gre recall (Z-2067-2015)Nidek Inc2015-07-14
Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator System; GYC4EP recall (Z-2068-2015)Nidek Inc2015-07-14
EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000 Quest. Optha recall (Z-1710-2015)Nidek Inc2015-06-04
YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment o recall (Z-1367-2015)Nidek Inc2015-04-02
MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for recall (Z-1127-2015)Nidek Inc2015-02-19
MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic device used recall (Z-0222-2015)Nidek Inc2014-11-17
Nidek Excimer Laser Corneal Surgery System, model EC-5000 CXIII. Opthalmic Device. The sys recall (Z-0223-2015)Nidek Inc2014-11-17
Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Devic recall (Z-0224-2015)Nidek Inc2014-11-17
GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoagulator Model GY recall (Z-2120-2014)Nidek Inc2014-08-13
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK C recall (Z-2132-2014)Nidek Inc2014-07-30
Non-Mydriatic Auto Fundus Camera. Model AFC-330. An ophthalmic camera for use in capturing recall (Z-1980-2014)Nidek Inc2014-07-02
RT-5100 Refractor and RT-3100 Refractor; Distributed by MARCO Opthalmic: Manufactured by N recall (Z-1853-2014)Nidek Inc2014-06-23
NAVIS-EX , Image Filing Software for NIDEK AFC Fundus camera, Ver 1.1.0 to 1.3.5. NAVIS-EX recall (Z-2046-2013)Nidek Inc2013-08-23

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Every clearance here is in the API, with alerts when new ones post.