Nidek Inc

FDA Filings

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

Nidek Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number2936921
FEI Number2936921
NameNIDEK INCORPORATED
Owner & OperatorNIDEK CO., LTD.
Contact Address34-14 MAEHAMA, HIROISHI-CHO --
GAMAGORI, AICHI JP-23 Aiti 4430038 JP
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address2040 Corporate Court
San Jose, CA 95131 US
Establishment TypeManufacture Medical Device

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
NIDEK INCORPORATED
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR2011-02-23
NIDEK INCORPORATED [NIDEK CO., LTD.]
PERIMETER2007-04-10
NIDEK, INC.
MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-3002004-12-14
NIDEK, INC.
NON-CONTACT TONOMETER, MODEL NT-40002003-12-04
NIDEK, INC.
GREEN LASER PHOTOCOAGULATOR MODEL GYC-10002003-10-03
NIDEK, INC.
NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)2002-11-19
NIDEK, INC.
ECHOSCAN, MODEL US-18002002-05-03
NIDEK, INC.
NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-10002002-04-17
NIDEK, INC.
DC-3300 LASER DIODE PHOTOCOAGULATOR2002-02-11
NIDEK, INC.
EPI-STAR SURGICAL LASER SYSTER2000-07-27
NIDEK, INC.
MICROKERATOME, MODEL MK-20001999-09-24
NIDEK, INC.
ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM1999-08-06
NIDEK, INC.
UNIPULSE CO2 SURGICAL LASER SYSTEM1998-12-16
NIDEK, INC.
NIDEK LIGHTSCAN1998-08-06
NIDEK, INC.
DIO-LIGHT 60 LASER SYSTEM1998-06-05
NIDEK, INC.
NIDEK PRIMA MODEL GYC-1500/20001998-05-13
NIDEK, INC.
NIDEK MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-70001998-03-18
NIDEK, INC.
DIO-LIGHT LASER SYSTEM1998-03-16
NIDEK, INC.
PRIMA KTP LASER SYSTEM1998-01-05
NIDEK, INC.
NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF)1997-11-04
NIDEK, INC.
NIDEK HANDY1997-11-04
NIDEK, INC.
NIDEK CYBERSCAN1997-03-18
NIDEK, INC.
CYBERLASE CO2 LASER SYSTEM1997-02-28
NIDEK, INC.
HANDPIECE FOR NIDEK CV-12000 PHACO SYSTEM1996-11-05
NIDEK, INC.
NIDEK MODEL GYC-1500 AND GYC-20001995-09-14
NIDEK, INC.
STORZ MICROSEAL PHACOEMULSIFICATION NEEDLES (IMPORTATION)1995-07-19
NIDEK, INC.
NIDEK MODEL VT-4000, MODIFICATION1994-07-15
NIDEK, INC.
NIDEK MODEL AC-23001993-11-22
NIDEK, INC.
NIDEK MODEL VST-40001993-03-29
NIDEK, INC.
NIDEK CV-120001993-03-26
NIDEK, INC.
DISPOSABLE SUPPLIES KIT FOR PEA PROCEDURE1991-12-24
NIDEK, INC.
NIDEK MODELS AC-2100 & 22001991-10-21
NIDEK, INC.
NIDEK MODEL NT-10001991-10-15
NIDEK, INC.
NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR1991-02-04
NIDEK, INC.
NIDEK INC. MODEL AC-2000 DERM1990-12-07
NIDEK, INC.
NIDEK US-20001990-11-21
NIDEK, INC.
NIDEK US-2500 W/BIOMETRY UNIT US-25201990-10-09
NIDEK, INC.
NIDEK, INC. MODEL ADC-8000 DERM1990-09-10
NIDEK, INC.
NIDEK MODEL AKC-8000 OPHTHALMIC LASER PHOTOCOAGULA1990-09-10
NIDEK, INC.
AR-1600G AUTO-REFRACTOMETER1990-07-27
NIDEK, INC.
MODEL YC-1200/PHOTOCOAGULATOR OPHTHALMIC LASER1990-06-20
NIDEK, INC.
NIDEK/PHACO EMULSIFICATION SYSTEM MODEL CV-80001990-06-08
NIDEK, INC.
NIDEK RT-1200S (MARCO TRS-1200)1990-06-08
NIDEK, INC.
NIDEK, INC. MODELS YC-1100 OPHTHALMIC LASERS1990-03-27
NIDEK, INC.
NIDEK, INC. BIO-DC LASER DELIVERY SYSTEM1990-03-22
NIDEK, INC.
 ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001990-03-13
NIDEK, INC.
MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR1989-10-16
NIDEK, INC.
NIDEK MODEL ADC-80001989-10-04
NIDEK, INC.
 ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001989-09-08
NIDEK, INC.
 ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001989-08-30
NIDEK, INC.
NIDEK MODEL YC-12001989-08-18
NIDEK, INC.
NIDEK MODEL AKC-80001989-08-07
NIDEK, INC.
NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS1989-06-22
NIDEK, INC.
NIDEK AR-12001989-02-27
NIDEK, INC.
OMRON ULTRASONIC NEBULIZER NE-U061988-12-05
NIDEK, INC.
NIDEK LM-870 AUTOMATIC LENSMETER1988-11-23
NIDEK, INC.
NIDEK OPEATING MICROSCOPE DELIVERY SYSTEM (OMDS)1988-09-15
NIDEK, INC.
NIDEK US-30001988-08-19
NIDEK, INC.
 ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001988-07-28
NIDEK, INC.
NIDEK ARK-20001988-07-01
NIDEK, INC.
NIDEK CV-40001988-05-25
NIDEK, INC.
NIDEK UP-20001988-03-15
NIDEK, INC.
NIDEK ADC-8000 LASER SYSTEM1987-10-15
NIDEK, INC.
 ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001987-06-11
NIDEK, INC.
 ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001987-04-08
NIDEK, INC.
 ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001986-12-01
NIDEK, INC.
NIDEK KM-1000 SURGICAL KERATOMETER1986-07-23
NIDEK, INC.
LM-850 AUTOMATIC LENSMETER1986-04-15
NIDEK, INC.
AR-1100 AUTOMATIC REFRACTOR1986-04-09
NIDEK, INC.
NIDEK US-1600 A-SCAN1986-04-08
NIDEK, INC.
AR-1000 AUTOMATIC REFRACTOR1986-04-04
NIDEK, INC.
NIDEK KM-800 AUTO KERATOMETER1986-04-04
NIDEK, INC.
AR-1600 AUTOMATIC REFRACTOR1986-04-04
NIDEK, INC.
NIDEK AC-2000 LASER SYSTEM1986-02-07
NIDEK, INC.
 ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001985-11-26
NIDEK, INC.
 ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001985-05-02
NIDEK, INC.
MONOCULAR DIRECT OPHTHALMOSCOPE1985-02-15
NIDEK, INC.
NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE1985-02-15
NIDEK, INC.
NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE1985-02-15
NIDEK, INC.
 ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001985-02-14
NIDEK, INC.
ARGON LASER PHOTOCOAGULATOR SYS REPEAT MODE1984-12-24
NIDEK, INC.
ARGON/KRYPTON & KRYPTON LASER PHOTOCOAGULATION SYS1984-12-24
NIDEK, INC.
 ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001984-10-23
NIDEK, INC.
NIDEK DIGITAL KERATOMETER1984-10-05
NIDEK, INC.
 ND:YAG POSTERIOR CAPSULOTOMY MODEL 1001984-09-27
NIDEK, INC.
ARGON/KRYPTON ION LASER PHOTOCOAGULA1984-03-16
NIDEK, INC.
US-1000 ULTRASONIC IMAGING SYSTEM1983-08-16
NIDEK, INC.
SUN PHOTO-KERATOSCOPE1983-06-30
NIDEK, INC.
AUTO REFRACTOMETER1983-06-10

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE Code0P0T2NIDEK INCORPORATED
NCAGE Code3BJM3NIDEK INC
CAGE Code0P0T2NIDEK INCORPORATED
CAGE Code3BJM3NIDEK, INC
S.A.M. Registration0P0T2 [66524612]NIDEK INCORPORATED
SEC0000868603NIDEK INCORPORATED
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092643860Nagoya Ko ,Japan -> Los Angeles, CaliforniaMANUFACTURER CODE: JPNIDC0674GAM ELECTRIC SURGICAL INSTRUMENTS . . . .9 PCS
2020091952694Nagoya Ko ,Japan -> Los Angeles, CaliforniaMANUFACTURER CODE: JPNIDC0674GAM ELECTRIC SURGICAL INSTRUMENTS . . . .9 PCS
2020091852130Nagoya Ko ,Japan -> Los Angeles, CaliforniaMANUFACTURER CODE: JPNIDC0674GAM ELECTRIC SURGICAL INSTRUMENTS . . . .9 PCS
2020091426939Pusan,South Korea -> New York/Newark Area, Newark, New JerseyMANUFACTURER CODE:JPNIDC0674GAM LENS GRINDING MACHINES . . . .19 CTN
2020081352017Nagoya Ko ,Japan -> Los Angeles, CaliforniaELECTRIC SURGICAL INSTRUMENTS . . . . .22 CTN
2020072713199Pusan,South Korea -> New York/Newark Area, Newark, New JerseyLENS GRINDING MACHINES . . . . .5 CTN
2020071753601Nagoya Ko ,Japan -> Los Angeles, CaliforniaLENS GRINDING MACHINES . . . . .1 CAS
202005131666Singapore,Singapore -> Jacksonville, FloridaELECTRIC DIAGNOSTIC INSTRUMENTS . . . . .180 CTN
202005131666Singapore,Singapore -> Jacksonville, FloridaELECTRIC DIAGNOSTIC INSTRUMENTS . . . . .180 CTN
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