FDA Inspection
Stryker NeurovascularStryker Neurovascular – FDA Inspection, Dec 18, 2024
Record Details
This FDA Inspection record concerns Stryker Neurovascular, with an inspection on December 18, 2024, issued by the San Francisco District Office, covering medical devices & rad health.
- Company
- Stryker Neurovascular
- Inspection Date
- December 18, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 8d0493c2-985c-4955-86c1-f6f0f5fa478d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1257117
- FDA center
- Medical Devices & Rad Health
- Project area
- Product Evaluation: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 812.40Sponsors' general responsibilities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Stryker Neurovascular
6| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 22, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 1, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 30, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 15, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Stryker Neurovascular
- FDA Inspection 1028734 - 2017-10-16
- FDA Inspection 1032404 - 2017-09-22
- FDA Inspection 980716 - 2016-06-01
- FDA Inspection 936471 - 2015-07-30
- FDA Inspection 851608 - 2013-10-15
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