Medical Device Manufacturer · US , Mchenry , IL

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

77 submissions · 77 cleared · Since 1983

77

Total

77

Cleared

0

Denied

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

7 devices

1-7 of 7

Cleared May 03, 2002

ECHOSCAN, MODEL US-1800

Radiology · 46d

Cleared Nov 21, 1990

Radiology · 119d

Cleared Oct 09, 1990

NIDEK US-2500 W/BIOMETRY UNIT US-2520

Radiology · 131d

Cleared Aug 19, 1988

Radiology · 88d

Cleared Mar 15, 1988

Radiology · 68d

Cleared Apr 08, 1986

NIDEK US-1600 A-SCAN

Radiology · 159d

Cleared Aug 16, 1983

US-1000 ULTRASONIC IMAGING SYSTEM

Radiology · 29d