Nidek Co., Ltd. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Nidek Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX, Ophthalmic Yag Laser System YC-200, Ophthalmic Yag Laser System YC-200
20
Total
19
Cleared
0
Denied
Nidek Co., Ltd. has 19 FDA 510(k) cleared ophthalmic devices. Based in Lake Forest, US.
Last cleared in 2023. Active since 2001.
Browse the complete list of FDA 510(k) cleared ophthalmic devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Ora, Inc., Nidek Technologies Srl and Nidek Incorporated. 2 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Nidek Co., Ltd.
20 devices
Cleared
CT
Mar 30, 2023
Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing...
Ophthalmic
328d
Cleared
Dec 07, 2020
Ophthalmic Yag Laser System YC-200
Ophthalmic
49d
Cleared
Nov 15, 2019
Ophthalmic Yag Laser System YC-200
Ophthalmic
107d
Cleared
Apr 01, 2019
Microperimeter MP-3, Microperimeter MP-3 Type S
Ophthalmic
56d
Cleared
Jul 19, 2018
Image Filing Software NAVIS-EX
Ophthalmic
59d
Cleared
CT
Mar 14, 2018
Specular Microscope CEM-530
Ophthalmic
75d
Cleared
Jun 23, 2017
YELLOW LASER PHOTOCOAGULATOR YLC-500
Ophthalmic
143d
Cleared
May 19, 2017
SLIT LAMP SL-2000
Ophthalmic
151d
Cleared
Jun 06, 2016
MICROPERIMETER MP-3
Ophthalmic
258d
Cleared
May 02, 2016
Green Laser Photocoagulator GYC-500
Ophthalmic
234d
Cleared
Mar 17, 2016
Specular Microscope CEM- 530
Ophthalmic
267d
Cleared
Aug 12, 2014
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE...
Ophthalmic
285d