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Nidek Co., Ltd.

20 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX (K221320)Nidek Co., Ltd.2023-03-30
Ophthalmic Yag Laser System YC-200 (K203130)Nidek Co., Ltd.2020-12-07
Ophthalmic Yag Laser System YC-200 (K192045)Nidek Co., Ltd.2019-11-15
Microperimeter MP-3, Microperimeter MP-3 Type S (K190198)Nidek Co., Ltd.2019-04-01
Image Filing Software NAVIS-EX (K181345)Nidek Co., Ltd.2018-07-19
Specular Microscope CEM-530 (K173980)Nidek Co., Ltd.2018-03-14
YELLOW LASER PHOTOCOAGULATOR YLC-500 (K170302)Nidek Co., Ltd.2017-06-23
SLIT LAMP SL-2000 (K163564)Nidek Co., Ltd.2017-05-19
MICROPERIMETER MP-3 (K152729)Nidek Co., Ltd.2016-06-06
Green Laser Photocoagulator GYC-500 (K152603)Nidek Co., Ltd.2016-05-02
Specular Microscope CEM- 530 (K151706)Nidek Co., Ltd.2016-03-17
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT (K133358)Nidek Co., Ltd.2014-08-12
OPTICAL BIOMETER AL-SCAN (K133132)Nidek Co., Ltd.2014-06-11
RS-3000 ADVANCE (K132323)Nidek Co., Ltd.2014-02-19
SPECULAR MICROSCOPE CEM-530 (K130565)Nidek Co., Ltd.2013-11-27
NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT (K131894)Nidek Co., Ltd.2013-10-31
NIDEK RS-3000 (K121622)Nidek Co., Ltd.2013-03-14
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI (K111493)Nidek Co., Ltd.2011-07-27
OPHTHALMOSCOPE F-10 (K072259)Nidek Co., Ltd.2008-05-06
OPD-SCAN, MODELS ARK-10000 AND ARK-9000 (K003299)Nidek Co., Ltd.2001-03-09

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