Medical Device Manufacturer · US , Mchenry , IL

Nidek, Inc. - FDA 510(k) Cleared Devices

77 submissions · 77 cleared · Since 1983

Total

Cleared

Denied

Nidek, Inc. has 77 FDA 510(k) cleared medical devices. Based in Mchenry, US.

Historical record: 77 cleared submissions from 1983 to 2005. Primary specialty: Ophthalmic.

Browse the FDA 510(k) cleared devices submitted by Nidek, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Nidek, Inc.

77 devices

1-12 of 77

MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300

K042785 · GEX

General & Plastic Surgery · 69d

Cleared Dec 04, 2003

NON-CONTACT TONOMETER, MODEL NT-4000

K031733 · HKX

Ophthalmic · 183d

Cleared Oct 03, 2003

GREEN LASER PHOTOCOAGULATOR MODEL GYC-1000

K032085 · GEX

General & Plastic Surgery · 88d

Cleared Nov 19, 2002

NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS)

K013694 · NFJ

Ophthalmic · 377d

Cleared May 03, 2002

ECHOSCAN, MODEL US-1800

K020876 · IYO

Radiology · 46d

Cleared Apr 17, 2002

NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000

K014274 · HKI

Ophthalmic · 111d

Cleared Feb 11, 2002

DC-3300 LASER DIODE PHOTOCOAGULATOR

K013760 · HQF

Ophthalmic · 90d

Cleared Feb 08, 2002

MODIFICATION TO EPI-STAR SURGICAL LASER SYSTEM, M0DEL DS-60

K013864 · GEX

General & Plastic Surgery · 79d

Cleared Jul 27, 2000

EPI-STAR SURGICAL LASER SYSTER

K990119 · GEX

General & Plastic Surgery · 561d

Cleared Sep 24, 1999

MICROKERATOME, MODEL MK-2000

K990900 · HNO

Ophthalmic · 190d

Cleared Aug 06, 1999

ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM

K991284 · MXK

Ophthalmic · 113d

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Nidek, Inc. - FDA 510(k) Cleared Devices

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