FDA Inspection
Medtronic Navigation, Inc.Medtronic Navigation, Inc. – FDA Inspection, Feb 4, 2010
Record Details
This FDA Inspection record concerns Medtronic Navigation, Inc., with an inspection on February 4, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medtronic Navigation, Inc.
- Inspection Date
- February 4, 2010
- Product Type
- Devices
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ID · b33b291d-18ca-4e36-b4c0-ade2eec6d5f4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 645196
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 803.52(a)(1)Patient Name or Other Identifier
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.198(a)General
- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.30(d)Essential design outputs
- 21 CFR 820.80(d)(1)DMR required activities {see also 820.181}
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.100(a)(2)Investigation procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medtronic Navigation, Inc.
14| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2025 | Not classified | Denver District Office | |
| February 9, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 29, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 30, 2019 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| August 2, 2018 | Not classified | Denver District Office |
Other documents for Medtronic Navigation, Inc.
- FDA Inspection 1287072 - 2025-08-27
- FDA Inspection 1231178 - 2024-02-09
- FDA Inspection 1145034 - 2021-06-29
- FDA Inspection 1103549 - 2019-09-30
- FDA Inspection 1106068 - 2018-08-02
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