Company
United StatesStryker Neurovascular, Fremont, CA – FDA Inspections
Inspection records and compliance data for Stryker Neurovascular in Fremont, California. 7 FDA inspections on record, 2 Form 483s, last inspected December 18, 2024.
Company Profile
This profile covers Stryker Neurovascular based in Fremont, California, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Form 483s
- 2
- Warning letters
- 0
First inspected May 4, 2012. Last inspected December 18, 2024.
Most cited issue areas
- Complaints1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
- Report of Death or Serious Injury1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 18, 2024 | VAI | Medical Devices & Rad Health · Product Evaluation: Medical Devices | 1257117 |
| October 16, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1028734 |
| September 22, 2017 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1032404 |
| June 1, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 980716 |
| July 30, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 936471 |
| October 15, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 851608 |
| May 4, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 780183 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Stryker Neurovascular
FEI Number
3008853977
Address
47900 Bayside Pkwy, Fremont, California 94538, United States
Country
United States
ID: 75d76f13-3dbc-4078-a970-3bf0cbbf5a7b