NIDEK MEDICAL PRODUCTS, INC.

Matched from indexed company URL: NIDEK INCORPORATED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10392151039215NIDEK MEDICAL PRODUCTS, INC.1N2026-01-013949 VALLEY EAST INDUSTRIAL DR Birmingham AL US 35217
29369212936921NIDEK INCORPORATED1Y2026-01-016601 Cascades Court Suite 130 The Colony TX US 75056
80303923002807715NIDEK CO., LTD.1N2026-01-0134-14 MAEHAMA, HIROISHI-CHO GAMAGORI, AICHI JP 443-0038
30028077153002807715NIDEK CO., LTD. HAMACHO PLANT1N2026-01-0167-4 HAMA-CHO GAMAGORI, AICHI JP 4430036

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04987669101056DIGITAL MEDICAL SCOPE - DS-10EA Adapter is designed to connect the control unit of DS-10 and the existing endoscope in the market. The assembly system (control unit & DS-10EA Adapter & existing endoscope in the market) can be used to record digital photographs and video of the body.1-800-223-9044info@nidek.com
04987669101070DIGITAL MEDICAL SCOPE - The assembly system (control unit & DS-10EA Adapter & existing endoscope in the market) can be used to record digital photographs and video ofthe body.1-800-223-9044info@nidek.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
105821401558835P970053EC-5000 EXCIMER LASER SYSTEMLZS1998-12-17
105831401558835P970053EC-5000 EXCIMER LASER SYSTEMLZS1998-12-17
105841401558835P970053EC-5000 EXCIMER LASER SYSTEMLZS1998-12-17
105821028639338K991284ANTERIOR EYE-SEGMENT ANALYSIS SYSTEMMXK1999-08-06
105831028639338K991284ANTERIOR EYE-SEGMENT ANALYSIS SYSTEMMXK1999-08-06
105841028639338K991284ANTERIOR EYE-SEGMENT ANALYSIS SYSTEMMXK1999-08-06
105821647233620K990900MICROKERATOME, MODEL MK-2000HNO1999-09-24
105831647233620K990900MICROKERATOME, MODEL MK-2000HNO1999-09-24
105841647233620K990900MICROKERATOME, MODEL MK-2000HNO1999-09-24
105821362448720K980475UNIPULSE CO2 SURGICAL LASER SYSTEMGEX1998-12-16
105831362448720K980475UNIPULSE CO2 SURGICAL LASER SYSTEMGEX1998-12-16
105841362448720K980475UNIPULSE CO2 SURGICAL LASER SYSTEMGEX1998-12-16
105822056043032K973533NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)HKI1997-11-04
105832056043032K973533NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)HKI1997-11-04
105842056043032K973533NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)HKI1997-11-04
105822068301446K973218NIDEK HANDYHKI1997-11-04
105832068301446K973218NIDEK HANDYHKI1997-11-04
105842068301446K973218NIDEK HANDYHKI1997-11-04
105831335380394K930444MARCO STANDARD KERATOMETERSHJB1993-08-09
105841335380394K930444MARCO STANDARD KERATOMETERSHJB1993-08-09
105831923497356K930441MARCO STANDARD LENSMETERS 101,201HLM1993-07-06
105841923497356K930441MARCO STANDARD LENSMETERS 101,201HLM1993-07-06
105831129029559K901686NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000HQC1990-06-08
105841129029559K901686NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-8000HQC1990-06-08
105822007069954K900165NIDEK, INC. BIO-DC LASER DELIVERY SYSTEMGEX1990-03-22
105832007069954K900165NIDEK, INC. BIO-DC LASER DELIVERY SYSTEMGEX1990-03-22
105842007069954K900165NIDEK, INC. BIO-DC LASER DELIVERY SYSTEMGEX1990-03-22
105821596061383K893987NIDEK MODEL YC-1200LXS1989-08-18
105831596061383K893987NIDEK MODEL YC-1200LXS1989-08-18
105841596061383K893987NIDEK MODEL YC-1200LXS1989-08-18
105821646819016K861063NIDEK KM-800 AUTO KERATOMETERHLQ1986-04-04
105831646819016K861063NIDEK KM-800 AUTO KERATOMETERHLQ1986-04-04
105841646819016K861063NIDEK KM-800 AUTO KERATOMETERHLQ1986-04-04
105821355259963K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EXOBO2023-03-30
105831355259963K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EXOBO2023-03-30
105841355259963K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EXOBO2023-03-30
105821054094665K203130Ophthalmic Yag Laser System YC-200HQF2020-12-07
105831054094665K203130Ophthalmic Yag Laser System YC-200HQF2020-12-07
105841054094665K203130Ophthalmic Yag Laser System YC-200HQF2020-12-07
731461894422180K192693Nuvo Nano Portable Oxygen ConcentratorCAW2020-05-07
105821813875038K192045Ophthalmic Yag Laser System YC-200HQF2019-11-15
105831813875038K192045Ophthalmic Yag Laser System YC-200HQF2019-11-15
105841813875038K192045Ophthalmic Yag Laser System YC-200HQF2019-11-15
105821414236223K190198Microperimeter MP-3, Microperimeter MP-3 Type SHKI2019-04-01
105831414236223K190198Microperimeter MP-3, Microperimeter MP-3 Type SHKI2019-04-01
105841414236223K190198Microperimeter MP-3, Microperimeter MP-3 Type SHKI2019-04-01
105821473306629K181345Image Filing Software NAVIS-EXNFJ2018-07-19
105831473306629K181345Image Filing Software NAVIS-EXNFJ2018-07-19
105841473306629K181345Image Filing Software NAVIS-EXNFJ2018-07-19
105821421214689K173980Specular Microscope CEM-530NQE2018-03-14
105831421214689K173980Specular Microscope CEM-530NQE2018-03-14
105841421214689K173980Specular Microscope CEM-530NQE2018-03-14
105821931355380K170302YELLOW LASER PHOTOCOAGULATOR YLC-500HQF2017-06-23
105831931355380K170302YELLOW LASER PHOTOCOAGULATOR YLC-500HQF2017-06-23
105841931355380K170302YELLOW LASER PHOTOCOAGULATOR YLC-500HQF2017-06-23
105821849559713K163564SLIT LAMP SL-2000HJO2017-05-19
105831849559713K163564SLIT LAMP SL-2000HJO2017-05-19
105841849559713K163564SLIT LAMP SL-2000HJO2017-05-19
105822063730380K152729MICROPERIMETER MP-3HKI2016-06-06
105832063730380K152729MICROPERIMETER MP-3HKI2016-06-06
105842063730380K152729MICROPERIMETER MP-3HKI2016-06-06
105821549153499K152603Green Laser Photocoagulator GYC-500HQF2016-05-02
105831549153499K152603Green Laser Photocoagulator GYC-500HQF2016-05-02
105841549153499K152603Green Laser Photocoagulator GYC-500HQF2016-05-02
105821404222242K151706Specular Microscope CEM- 530NQE2016-03-17
105831404222242K151706Specular Microscope CEM- 530NQE2016-03-17
105841404222242K151706Specular Microscope CEM- 530NQE2016-03-17
105821387092958K133358NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNITHQF2014-08-12
105831387092958K133358NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNITHQF2014-08-12
105841387092958K133358NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNITHQF2014-08-12
105821389817901K133132OPTICAL BIOMETER AL-SCANHJO2014-06-11
105831389817901K133132OPTICAL BIOMETER AL-SCANHJO2014-06-11
105841389817901K133132OPTICAL BIOMETER AL-SCANHJO2014-06-11
105821922410846K132323RS-3000 ADVANCEOBO2014-02-19
105831922410846K132323RS-3000 ADVANCEOBO2014-02-19
105841922410846K132323RS-3000 ADVANCEOBO2014-02-19
105821138599390K130565SPECULAR MICROSCOPE CEM-530NQE2013-11-27
105831138599390K130565SPECULAR MICROSCOPE CEM-530NQE2013-11-27
105841138599390K130565SPECULAR MICROSCOPE CEM-530NQE2013-11-27
731461913222471K123738MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STDCAW2013-02-28
105821163938209K121622NIDEK RS-3000OBO2013-03-14
105831163938209K121622NIDEK RS-3000OBO2013-03-14
105841163938209K121622NIDEK RS-3000OBO2013-03-14
105841855852347K120982DIGITAL EYE-FUNDUS CAMERAHKI2012-09-28
105821268906056K113451NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EXHKI2012-05-08
105831268906056K113451NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EXHKI2012-05-08
105841268906056K113451NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EXHKI2012-05-08
105822009702827K111493NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXIHQB2011-07-27
105832009702827K111493NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXIHQB2011-07-27
105842009702827K111493NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXIHQB2011-07-27
105821050845722K110228NIDEK MULTICOLOR LASER PHOTOCOAGULATORHQB2011-02-23
105831050845722K110228NIDEK MULTICOLOR LASER PHOTOCOAGULATORHQB2011-02-23
105841050845722K110228NIDEK MULTICOLOR LASER PHOTOCOAGULATORHQB2011-02-23
731462036666831K093308MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STDCAW2010-01-14
105821253555942K072259OPHTHALMOSCOPE F-10MYC2008-05-06
105831253555942K072259OPHTHALMOSCOPE F-10MYC2008-05-06
105841253555942K072259OPHTHALMOSCOPE F-10MYC2008-05-06
105821075104613K061768MP-1 MICROPERIMETERHKI2006-09-28
105831075104613K061768MP-1 MICROPERIMETERHKI2006-09-28
105841075104613K061768MP-1 MICROPERIMETERHKI2006-09-28
105821662694721K050336OPD-STATION SOFTWARENCF2005-08-24
105831662694721K050336OPD-STATION SOFTWARENCF2005-08-24
105841662694721K050336OPD-STATION SOFTWARENCF2005-08-24
105821990307908K042785MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300GEX2004-12-14

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HKI252019-04-01
HQF222020-12-07
NQE122018-03-14
GEX122004-12-14
OBO92023-03-30
HQB82011-07-27
HJO72017-05-19
HLQ62001-03-09
NFJ42018-07-19
IYO42002-05-03
LZS41998-12-17
LXS41989-08-18
CAW32020-05-07
MYC32008-05-06
NCF32005-08-24
HKX32003-12-04
HNO31999-09-24
MXK31999-08-06
HJB21993-08-09
HLM21993-07-06
HQC21990-06-08
BTI12002-05-03

PMA#

PMN#

113 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next