Northern Digital Inc.
FDA Regulatory Profile
Northern Digital Inc. appears in FDA public data with 2 recalls, 1 510(k) clearance, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-2084-2015, Class II) was initiated on June 10, 2015. Its most recent 510(k) clearance was granted on January 27, 2004.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2084-2015 | Class II | NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Produ | June 10, 2015 |
| Z-2093-2015 | Class II | NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgery) system. Product | May 20, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K033621 | NDI PASSIVE SPHERES | January 27, 2004 |