Medical Device Manufacturer · US , Golden , CO

Nicolet Biomedical - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1998

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Nicolet Biomedical Radiology ✕

5 devices

1-5 of 5

Cleared Apr 21, 2003

NICOLET PIONEER TC8080

Radiology · 410d

Cleared Dec 20, 2001

NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM

Radiology · 66d

Cleared Mar 09, 2001

NICOLET VERSALAB

Radiology · 15d

Cleared Jun 29, 2000

NICOLET EME LEGEND TC22

Radiology · 223d

Cleared Aug 07, 1998

Radiology · 25d