Company
United StatesCardiva Medical, Inc., Santa Clara, CA – FDA Inspections
Inspection records and compliance data for Cardiva Medical, Inc. in Santa Clara, California. 8 FDA inspections on record, 2 Form 483s, last inspected July 21, 2023.
Company Profile
This profile covers Cardiva Medical, Inc. based in Santa Clara, California, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 2
- NAI
- 6
- Form 483s
- 2
- Warning letters
- 0
First inspected September 3, 2009. Last inspected July 21, 2023.
Most cited issue areas
- Documentation1 inspection
- Lack of or inadequate procedures1 inspection
- Quality System Procedures1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 21, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1211273 |
| March 14, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1084157 |
| May 10, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1014545 |
| March 25, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 871451 |
| November 19, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 809441 |
| October 30, 2012 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 807691 |
| May 4, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 780138 |
| September 3, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 609929 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Cardiva Medical, Inc.
FEI Number
3015145497
Address
1615 Wyatt Dr, Santa Clara, California 95054, United States
Country
United States
ID: d2c13d97-eb8f-4b56-bcf4-052d6081107f