Company
United StatesPublic company, NASDAQ: ATRCAtriCure, Inc. (NASDAQ: ATRC), Mason, OH – FDA Inspections
Inspection records and compliance data for AtriCure, Inc. in Mason, Ohio. 12 FDA inspections on record, 3 Form 483s, last inspected December 13, 2018. Publicly traded as NASDAQ: ATRC.
Company Profile
This profile covers AtriCure, Inc. based in Mason, Ohio, United States.
FDA Inspection History
- FDA inspections
- 12
- OAI
- 0
- VAI
- 3
- NAI
- 7
- Unclassified
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected June 21, 2010. Last inspected December 13, 2018.
Most cited issue areas
- Design validation - Risk analysis1 inspection
- Documentation1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (12)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 13, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1077020 |
| March 9, 2018 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1055553 |
| March 9, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1043957 |
| October 5, 2017 | Not classified | Medical Devices & Rad Health | 1042648 |
| August 24, 2017 | Not classified | Medical Devices & Rad Health | 1045711 |
| October 13, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 990475 |
| August 29, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 990228 |
| February 26, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 821138 |
| January 18, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 816941 |
| April 1, 2011 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 719406 |
| February 22, 2011 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 713759 |
| June 21, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 667871 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
AtriCure, Inc.
Stock ticker
ATRC
Exchange
NASDAQ
Share price
$61.37
Market cap
$3.1B
Price as of
November 6, 2026
FEI Number
3011706110
Address
7555 Innovation Way, Mason, Ohio 45040, United States
Country
United States
ID: 0f023ece-1b1d-43a8-8166-e427be422570