Company
United StatesLivaNova USA, Inc. - Inspection Records
Inspection records and compliance data for LivaNova USA, Inc. in Houston, Texas. 7 FDA inspections on record, last inspected January 16, 2026.
Company Profile
This profile covers LivaNova USA, Inc. based in Houston, Texas, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Unclassified
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected December 9, 2011. Last inspected January 16, 2026.
Most cited issue areas
- Complaints1 inspection
- Design verification - documentation1 inspection
- Incorrect translation to production specifications1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 16, 2026 | Not classified | Medical Devices & Rad Health | 1302110 |
| February 20, 2025 | Not classified | Medical Devices & Rad Health | 1261017 |
| August 12, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1180294 |
| May 4, 2021 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1141170 |
| August 22, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 891132 |
| December 7, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 808850 |
| December 9, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 759004 |
FDA documents
Form 483s (1)
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Company Information
Name
LivaNova USA, Inc.
FEI Number
1000117004
Address
100 Cyberonics Blvd, Houston, Texas 77058, United States
Country
United States
ID: 3eed84aa-5d07-449c-a020-ff8b2c23ca35