Northern Digital Inc.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
1
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2084-2015Class IINDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. ProduJune 10, 2015
Z-2093-2015Class IINDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product May 20, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K033621NDI PASSIVE SPHERESJanuary 27, 2004