FEI 3002743211
Northern Digital, Inc.
103 RANDALL DRIVE, WATERLOO Ontario, CA
MDR events108All time
Recalls2All time
Registered products2
Establishment typeExportExport Device to the United States But Perform No Other Operation on Device
Registered product codes
2 product codes
Recent MDR events
108 on file
- NDI PASSIVE SPHERESSep 5, 2025Malfunction3002743211-2025-00066
- NDI PASSIVE SPHERESMay 28, 2025Malfunction3002743211-2025-00001
- NDI PASSIVE SPHERESMar 26, 2024MalfunctionMW5153214
- NDI PASSIVE MARKER SPHERESFeb 11, 2016Malfunction3002743211-2016-00001
- NDI PASSIVE MARKER SPHERESFeb 11, 2016Malfunction3002743211-2016-00002
- DISPOSABLE REFLECTIVE MARKER SPHERESOct 8, 2015Malfunction3002743211-2015-00056
- NDI PASSIVE SPHERESSep 29, 2015Malfunction3002743211-2015-00054
- NDI PASSIVE SPHERESSep 29, 2015Malfunction3002743211-2015-00055
- NDI PASSIVE SPHERESSep 18, 2015Malfunction3002743211-2015-00051
- NDI PASSIVE SPHERESSep 18, 2015Malfunction3002743211-2015-00052
Compliance history
Matched by FEI 3002743211.
FDA inspections
4 on file
- Official Action Indicated (OAI)Aug 28, 2025
Compliance: Devices · Citations posted
- Official Action Indicated (OAI)Aug 28, 2025
Postmarket Assurance: Devices · Citations posted
- No Action Indicated (NAI)Aug 14, 2024
Compliance: Devices
- No Action Indicated (NAI)Aug 14, 2024
Postmarket Assurance: Devices
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.17Aug 28, 2025
Lack of Written MDR Procedures
- 21 CFR 820.25(a)Aug 28, 2025
Personnel
- 21 CFR 820.50Aug 28, 2025
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(a)Aug 28, 2025
Lack of or inadequate complaint procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.