Company
United StatesHansen Medical Inc, Mountain View, CA – FDA Inspections
Inspection records and compliance data for Hansen Medical Inc in Mountain View, California. 4 FDA inspections on record, last inspected August 29, 2016.
Company Profile
This profile covers Hansen Medical Inc based in Mountain View, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected June 28, 2010. Last inspected August 29, 2016.
Most cited issue areas
- Report of Death or Serious Injury1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 29, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 988550 |
| September 3, 2015 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 941902 |
| October 16, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 899020 |
| June 28, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 669351 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hansen Medical Inc
FEI Number
3006026430
Address
800 E Middlefield Rd, Mountain View, California 94043, United States
Country
United States
ID: 79007345-51cf-45bc-b457-8bafe5dc61f0