FDA Inspection
Medtronic Navigation, Inc.-BoxboroughMedtronic Navigation, Inc.-Boxborough – FDA Inspection, Jun 11, 2024
Record Details
This FDA Inspection record concerns Medtronic Navigation, Inc.-Boxborough, with an inspection on June 11, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · bb0a2da4-0668-4086-b1ab-18d587eb3647
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1240926
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.184DHR - not or inadequately maintained
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medtronic Navigation, Inc.-Boxborough
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 3, 2018 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| March 17, 2016 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 11, 2013 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| September 26, 2011 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 15, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medtronic Navigation, Inc.-Boxborough
- FDA Inspection 1036654 - 2018-01-03
- FDA Inspection 963291 - 2016-03-17
- FDA Inspection 848319 - 2013-09-11
- FDA Inspection 746701 - 2011-09-26
- FDA Inspection 667059 - 2010-06-15
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