Nidek Co L T D

FDA Filings

This page includes the latest FDA filings for Nidek Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 8030392
• FEI Number: 3002807715
• Name: Todd Milholland
• Owner & Operator: NIDEK CO., LTD.
• Contact Address: 34-14 MAEHAMA, HIROISHI-CHO --; GAMAGORI, AICHI JP-23 Aiti 4430038 JP
• US Agent:
  • Todd Milholland
  • NIDEK INCORPORATED
  • 408 7056356
  • todd_milholland@nidek.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2040 Corporate Court ; San Jose, CA 95131 US
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3002807715
• FEI Number: 3002807715
• Name: Todd Milholland
• Owner & Operator: NIDEK CO., LTD.
• Contact Address: 34-14 MAEHAMA, HIROISHI-CHO --; GAMAGORI, AICHI JP-23 Aiti 4430038 JP
• US Agent:
  • Todd Milholland
  • NIDEK INCORPORATED
  • 408 7056356
  • todd_milholland@nidek.com
• Importing Logistics Registration:
  • Importer: NIDEK Inc.
  • Address: 47651 WESTINGHOUSE DR. ; Fremont, CA 94539 UNITED STATES
  • Email Address: Toshio_Murata@nidek.com
  • Phone: 1 510 3537789
  • FAX: 1 510 2265750
  • Importer Type: AGENT
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2040 Corporate Court ; San Jose, CA 95131 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

• Registration Number: 2936921
• FEI Number: 2936921
• Name: NIDEK INCORPORATED
• Owner & Operator: NIDEK CO., LTD.
• Contact Address: 34-14 MAEHAMA, HIROISHI-CHO --; GAMAGORI, AICHI JP-23 Aiti 4430038 JP
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2040 Corporate Court ; San Jose, CA 95131 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 04987669200780 NIDEK CO.,LTD.	IOL-Station	2023-07-18
GUDID 04987669200117 NIDEK CO.,LTD.	A-scan probe	2023-07-18
GUDID 04987669200100 NIDEK CO.,LTD.	Pachymetry probe (45° fixed type)	2023-07-18
GUDID 04987669200094 NIDEK CO.,LTD.	Pachymetry probe	2023-07-18
GUDID 04987669200070 NIDEK CO.,LTD.	A-scan probe	2023-07-18
GUDID 04987669200049 NIDEK CO.,LTD.	Pachymetry probe (45° fixed type)	2023-07-18
GUDID 04987669200018 NIDEK CO.,LTD.	A-scan probe	2023-07-18
GUDID 04987669607350 NIDEK CO.,LTD.	CEM Viewer for NAVIS-EX	2023-06-20
GUDID 04987669203651 NIDEK CO.,LTD.	OPTICAL BIOMETER 32NNNN	2023-06-20
GUDID 04987669203477 NIDEK CO.,LTD.	OPTICAL BIOMETER 39NNNN	2023-06-20
GUDID 04987669200773 NIDEK CO.,LTD.	AL-Scan Viewer for NAVIS-EX	2023-06-20
GUDID 04987669200636 NIDEK CO.,LTD.	Image filing software NAVIS-EX	2023-06-20
GUDID 04987669101711 NIDEK CO.,LTD.	REFRACTOR	2023-06-20
GUDID 04987669101568 NIDEK CO.,LTD.	Scanning Laser Ophthalmoscope	2023-06-20
GUDID 04987669101544 NIDEK CO.,LTD.	MICROPERIMETER	2023-06-20
GUDID 04987669100844 NIDEK CO.,LTD.	IOL-Station	2023-06-20
GUDID 04987669101575 NIDEK CO.,LTD.	CHART PROJECTOR	2021-10-11
GUDID 04987669101650 NIDEK CO.,LTD.	YAG laser combination delivery unit (YC-200)	2021-10-04
GUDID 04987669101452 NIDEK CO.,LTD.	Ophthalmic YAG Laser System	2021-10-04
GUDID 04987669101476 NIDEK CO.,LTD.	AUTO REF/KERATOMETER	2020-03-05
GUDID 04987669101469 NIDEK CO.,LTD.	AUTO REFRACTOMETER	2020-03-05
GUDID 04987669100776 NIDEK CO.,LTD.	REFRACTIVE POWER / CORNEAL ANALYZER	2020-03-05
GUDID 04987669100769 NIDEK CO.,LTD.	HANDHELD REF / KERATOMETER	2020-03-05
GUDID 04987669100752 NIDEK CO.,LTD.	HANDHELD REFRACTOMETER	2020-03-05
GUDID 04987669100745 NIDEK CO.,LTD.	AUTO REF/KERATOMETER	2020-03-05
GUDID 04987669100738 NIDEK CO.,LTD.	AUTO REF/KERATOMETER	2020-03-05
GUDID 04987669100721 NIDEK CO.,LTD.	AUTO REF/KERATOMETER	2020-03-05
GUDID 04987669100714 NIDEK CO.,LTD.	AUTO REF/KERATOMETER	2020-03-05
GUDID 04987669100707 NIDEK CO.,LTD.	AUTO REFRACTOMETER	2020-03-05
GUDID 04987669100691 NIDEK CO.,LTD.	AUTO REFRACTOMETER	2020-03-05
GUDID 04987669100684 NIDEK CO.,LTD.	AUTO REFRACTOMETER	2020-03-05
GUDID 04987669100066 NIDEK CO.,LTD.	AUTO REF/KERATO/TONOMETER	2020-03-05
GUDID 04987669101407 NIDEK CO.,LTD.	AUTO LENSMETER	2019-12-17
GUDID 04987669101391 NIDEK CO.,LTD.	AUTO LENSMETER	2019-12-17
GUDID 04987669100639 NIDEK CO.,LTD.	AUTO LENSMETER	2019-12-17
PMN K192045 Nidek Co., Ltd.	Ophthalmic Yag Laser System YC-200	2019-11-15
GUDID 04987669100981 NIDEK CO.,LTD.	Endophotocoagulation Delivery Unit	2019-09-16
GUDID 04987669100974 NIDEK CO.,LTD.	Endophotocoagulation Delivery Unit	2019-09-16
GUDID 04987669101520 NIDEK CO.,LTD.	Space Saving Chart	2019-07-22
GUDID 04987669101445 NIDEK CO.,LTD.	REFRACTOR	2019-07-22
GUDID 04987669101414 NIDEK CO.,LTD.	Tabletop Refraction System	2019-07-22
GUDID 04987669100653 NIDEK CO.,LTD.	SYSTEM CHART	2019-07-22
GUDID 04987669100646 NIDEK CO.,LTD.	SPACE SAVING CHART	2019-07-22
GUDID 04987669101490 NIDEK CO.,LTD.	System Table	2019-04-03
GUDID 04987669101483 NIDEK CO.,LTD.	System Table	2019-04-03
PMN K190198 Nidek Co., Ltd	Microperimeter MP-3, Microperimeter MP-3 Type S	2019-04-01
GUDID 04987669101421 NIDEK CO.,LTD.	Data Acquisition Service for NAVIS-EX	2018-09-24
GUDID 04987669101360 NIDEK CO.,LTD.	AL-Scan Viewer for NAVIS-EX	2018-09-24
GUDID 04987669101353 NIDEK CO.,LTD.	CEM Viewer for NAVIS-EX	2018-09-24
GUDID 04987669100554 NIDEK CO.,LTD.	NON-MYDRIATIC AUTO FUNDUS CAMERA	2018-09-24
GUDID 04987669100523 NIDEK CO.,LTD.	Image filing software	2018-09-24
PMN K181345 Nidek Co., Ltd	Image Filing Software NAVIS-EX	2018-07-19
GUDID 04987669100417 NIDEK CO.,LTD.	Sterilized Endophoto Probe(25G/Coaxial)	2018-05-24
GUDID 04987669100400 NIDEK CO.,LTD.	Sterilized Endophoto Probe(23G/Coaxial)	2018-05-24
GUDID 04987669100394 NIDEK CO.,LTD.	Sterilized Endophoto Probe(20G/Coaxial)	2018-05-24
GUDID 04987669100387 NIDEK CO.,LTD.	Sterilized Endophoto Probe(27G/Straight)	2018-05-24
GUDID 04987669100370 NIDEK CO.,LTD.	Sterilized Endophoto Probe(25G/Angled)	2018-05-24
GUDID 04987669100363 NIDEK CO.,LTD.	Sterilized Endophoto Probe(25G/Straight)	2018-05-24
GUDID 04987669100356 NIDEK CO.,LTD.	Sterilized Endophoto Probe(23G/Angled)	2018-05-24
GUDID 04987669100349 NIDEK CO.,LTD.	Sterilized Endophoto Probe(23G/Straight)	2018-05-24
GUDID 04987669100332 NIDEK CO.,LTD.	Sterilized Endophoto Probe(20G/Angled)	2018-05-24
GUDID 04987669100325 NIDEK CO.,LTD.	Sterilized Endophoto Probe(20G/Straight)	2018-05-24
GUDID 04987669101216 NIDEK CO.,LTD.	Scan Attachable delivery unit (900BQ)	2018-05-21
GUDID 04987669101186 NIDEK CO.,LTD.	Scan slit lamp delivery unit (NIDEK SL)	2018-05-21
GUDID 04987669101179 NIDEK CO.,LTD.	Scan Attachable delivery unit (SL130)	2018-05-21
GUDID 04987669101162 NIDEK CO.,LTD.	Bio delivery unit (OMEGA 500)	2018-05-21
GUDID 04987669101131 NIDEK CO.,LTD.	Slit lamp delivery unit (NIDEK SL)	2018-05-21
GUDID 04987669101124 NIDEK CO.,LTD.	Attachable delivery unit (SL130)	2018-05-21
GUDID 04987669101117 NIDEK CO.,LTD.	Yellow Laser Photocoagulator	2018-05-21
GUDID 04987669100837 NIDEK CO.,LTD.	PD Meter	2018-05-21
GUDID 04987669100813 NIDEK CO.,LTD.	REFRACTOR	2018-05-21
GUDID 04987669100806 NIDEK CO.,LTD.	SYSTEM TABLE	2018-05-21
GUDID 04987669100622 NIDEK CO.,LTD.	AUTO LENSMETER	2018-05-21
GUDID 04987669100561 NIDEK CO.,LTD.	OPHTHALMOSCOPE	2018-05-21
GUDID 04987669100455 NIDEK CO.,LTD.	ECHOSCAN	2018-04-25
GUDID 04987669100448 NIDEK CO.,LTD.	ECHOSCAN	2018-04-25
GUDID 04987669100288 NIDEK CO.,LTD.	BIO delivery unit (Heine OMEGA)	2018-03-29
GUDID 04987669100271 NIDEK CO.,LTD.	BIO delivery unit (Keeler)	2018-03-29
GUDID 04987669100264 NIDEK CO.,LTD.	Attachable delivery unit (900BQ)	2018-03-29
GUDID 04987669100257 NIDEK CO.,LTD.	Attachable delivery unit (900BQ)	2018-03-29
GUDID 04987669100240 NIDEK CO.,LTD.	Attachable delivery unit (SL130)	2018-03-29
GUDID 04987669100233 NIDEK CO.,LTD.	Attachable delivery unit (SL-1800)	2018-03-29
GUDID 04987669100226 NIDEK CO.,LTD.	Attachable delivery unit (30SL)	2018-03-29
GUDID 04987669100219 NIDEK CO.,LTD.	Slit lamp delivery unit (SL-1800)	2018-03-29
GUDID 04987669100202 NIDEK CO.,LTD.	GREEN LASER PHOTOCOAGULATOR SYSTEM	2018-03-29
GUDID 04987669100196 NIDEK CO.,LTD.	Scan slit lamp delivery unit (SL-1800)	2018-03-29
GUDID 04987669100189 NIDEK CO.,LTD.	Scan attachable delivery unit (900BQ)	2018-03-29
GUDID 04987669100172 NIDEK CO.,LTD.	Scan attachable delivery unit (SL130)	2018-03-29
GUDID 04987669100165 NIDEK CO.,LTD.	Scan attachable delivery unit (SL-1800)	2018-03-29
GUDID 04987669100158 NIDEK CO.,LTD.	Scan attachable delivery unit (30SL/M)	2018-03-29
GUDID 04987669100141 NIDEK CO.,LTD.	Attachable delivery unit (SL130)	2018-03-29
GUDID 04987669100134 NIDEK CO.,LTD.	Attachable delivery unit (SL-1800)	2018-03-29
GUDID 04987669100127 NIDEK CO.,LTD.	Attachable delivery unit (30SL)	2018-03-29
GUDID 04987669100110 NIDEK CO.,LTD.	BIO delivery unit (Heine OMEGA)	2018-03-29
GUDID 04987669100103 NIDEK CO.,LTD.	YAG laser combination delivery unit (YC-1800)	2018-03-29
GUDID 04987669100097 NIDEK CO.,LTD.	Slit lamp delivery unit (SL-1800)	2018-03-29
GUDID 04987669100080 NIDEK CO.,LTD.	Multicolor Laser Photocoagulator	2018-03-29
GUDID 04987669100073 NIDEK CO.,LTD.	OPHTHALMIC YAG LASER SYSTEM	2018-03-29
GUDID 04987669100059 NIDEK CO.,LTD.	CHART PROJECTOR	2018-03-29
GUDID 04987669100042 NIDEK CO.,LTD.	Final Fit™	2018-03-29
GUDID 04987669100035 NIDEK CO.,LTD.	Final Fit™	2018-03-29
GUDID 04987669100028 NIDEK CO.,LTD.	Quest™	2018-03-29
GUDID 04987669100011 NIDEK CO.,LTD.		2018-03-29
PMN K173980 Nidek Co., Ltd.	Specular Microscope CEM-530	2018-03-14
PMA P970053S017 NIDEK CO., LTD.	Nidek EC-5000 Excimer Laser System	2018-01-12
PMN K170302 NIDEK CO., LTD.	YELLOW LASER PHOTOCOAGULATOR YLC-500	2017-06-23
PMA P970053S016 NIDEK CO., LTD.	EC-5000 EXCIMER LASER SYSTEM	2017-06-08
PMN K163564 NIDEK CO., LTD.	SLIT LAMP SL-2000	2017-05-19
PMN K152729 NIDEK CO., LTD.	MICROPERIMETER MP-3	2016-06-06
PMN K152603 NIDEK CO., LTD.	Green Laser Photocoagulator GYC-500	2016-05-02
PMN K151706 NIDEK CO., LTD.	Specular Microscope CEM- 530	2016-03-17
FSP Todd Milholland [NIDEK CO., LTD.]	Digital Medical Scope DS-10D	2015-11-17
PMA P970053S015 NIDEK CO., LTD.	NIDEK EXCLAIMER LASER SYSTEM EC-5000	2015-03-30
PMA P970053S013 NIDEK CO., LTD.	NIDEK EXCIMER LASER SYSTEM EC-5000	2014-11-21
PMA P970053S014 NIDEK CO., LTD.	NIDEK EXCIMER LASER SYSTEM EC-5000	2014-11-14
PMN K133358 NIDEK CO., LTD	NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT	2014-08-12
PMN K133132 NIDEK CO., LTD.	OPTICAL BIOMETER AL-SCAN	2014-06-11
PMN K132323 NIDEK CO., LTD.	RS-3000 ADVANCE	2014-02-19
PMN K130565 NIDEK CO., LTD.	SPECULAR MICROSCOPE CEM-530	2013-11-27
PMN K131894 NIDEK CO., LTD.	NIDEK GREEN LASER PHOTOCOAGULTOR MODEL GYC-1000 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT	2013-10-31
PMA P970053S011 NIDEK CO., LTD.	NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM	2013-09-30
PMN K121622 NIDEK CO., LTD.	NIDEK RS-3000	2013-03-14
PMA P970053S012 NIDEK CO., LTD.	NIDEK EC-5000 EXCIMER LASER SYSTEM	2012-12-12
PMN K111493 NIDEK CO., LTD.	NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI	2011-07-27
PMN K072259 NIDEK CO., LTD.	OPHTHALMOSCOPE F-10	2008-05-06
HPT Todd Milholland [NIDEK CO., LTD.]	PERIMETER	2007-04-10
HPT Todd Milholland [NIDEK CO., LTD.]	PERIMETER	2007-04-10
HPT NIDEK INCORPORATED [NIDEK CO., LTD.]	PERIMETER	2007-04-10
PMA P970053S010 NIDEK CO., LTD.	NIDEK EC-5000 EXCIMER LASER	2006-11-08
PMA P970053S009 NIDEK CO., LTD.	NIDEK EC-5000 EXCIMER LASER SYSTEM	2006-10-11
PMA P970053S008 NIDEK CO., LTD.	NIDEK EC-5000 EXCIMER LASER SYSTEM	2004-05-28
PMA P970053S007 NIDEK CO., LTD.	NIDEK EC-5000 EXCIMER LASER SYSTEM	2002-10-28
PMA P970053S006 NIDEK CO., LTD.	NIDEK EC-5000 EXCIMER LASER SYSTEM	2001-09-04
PMA P970053S005 NIDEK CO., LTD.	NIDEK EC-5000 EXCIMER LASER SYSTEM	2001-03-15
PMN K003299 NIDEK CO., LTD.	OPD-SCAN, MODELS ARK-10000 AND ARK-9000	2001-03-09
PMA P970053S003 NIDEK CO., LTD.	EC-5000 EXCIMER LASER SYSTEM	2000-10-25
PMA P970053S002 NIDEK CO., LTD.	NIDEK EC-5000 EXCIMER LASER SYSTEM	2000-04-14
PMA P970053S001 NIDEK CO., LTD.	NIDEK EC-5000 EXCIMER LASER SYSTEM (PARK)	1999-09-29
PMA P970053 NIDEK CO., LTD.	EC-5000 EXCIMER LASER SYSTEM	1998-12-17

Related Finance Registrations

NCAGE Code	S7720	NIDEK CO. LTD
CAGE Code	S7720	NIDEK CO. LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092643860	Nagoya Ko ,Japan -> Los Angeles, California	MANUFACTURER CODE: JPNIDC0674GAM ELECTRIC SURGICAL INSTRUMENTS . . . .	9 PCS
2020091952694	Nagoya Ko ,Japan -> Los Angeles, California	MANUFACTURER CODE: JPNIDC0674GAM ELECTRIC SURGICAL INSTRUMENTS . . . .	9 PCS
2020091852130	Nagoya Ko ,Japan -> Los Angeles, California	MANUFACTURER CODE: JPNIDC0674GAM ELECTRIC SURGICAL INSTRUMENTS . . . .	9 PCS
2020091784099	Nagoya Ko ,Japan -> Tacoma, Washington	OPHTHALMIC INSTRUMENTS (9018.50)	52 CTN
2020091426939	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	MANUFACTURER CODE:JPNIDC0674GAM LENS GRINDING MACHINES . . . .	19 CTN
2020082737642	Nagoya Ko ,Japan -> Tacoma, Washington	OPHTHALMIC INSTRUMENTS (9018.50)	54 CTN
2020082545034	Nagoya Ko ,Japan -> Tacoma, Washington	OPHTHALMIC INSTRUMENTS (9018.50)	54 CTN
2020082448163	Nagoya Ko ,Japan -> Tacoma, Washington	OPHTHALMIC INSTRUMENTS (9018.50)	54 CTN