FDA Inspection
Stryker NeurovascularStryker Neurovascular – FDA Inspection, Oct 16, 2017
Record Details
This FDA Inspection record concerns Stryker Neurovascular, with an inspection on October 16, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 830feb26-c340-4730-a20c-71c55f4e6fc9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028734
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Stryker Neurovascular
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 18, 2024 | VAI | San Francisco District Office | Product Evaluation: Medical 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 1257117 - 2024-12-18
- 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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