Company
United StatesPublic company, NASDAQ: ISRGIntuitive Surgical, Inc. (NASDAQ: ISRG), Sunnyvale, CA – FDA Inspections
Inspection records and compliance data for Intuitive Surgical, Inc. in Sunnyvale, California. 10 FDA inspections on record (2 OAI), 2 Form 483s, 1 warning letter, last inspected November 05, 2025. Publicly traded as NASDAQ: ISRG.
Company Profile
This profile covers Intuitive Surgical, Inc. based in Sunnyvale, California, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 2
- VAI
- 2
- NAI
- 6
- Form 483s
- 2
- Warning letters
- 1
First inspected July 29, 2010. Last inspected November 5, 2025.
Most cited issue areas
- Lack of or inadequate procedures3 inspections
- Report of risk to health2 inspections
- Availability1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 5, 2025 | OAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1276877 |
| December 21, 2023 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1227392 |
| December 14, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1225346 |
| August 27, 2021 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1149960 |
| April 26, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1020267 |
| October 14, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 945068 |
| March 21, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 864084 |
| May 30, 2013 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 832849 |
| January 17, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 763673 |
| July 29, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 674822 |
FDA documents
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Company Information
Name
Intuitive Surgical, Inc.
Stock ticker
ISRG
Exchange
NASDAQ
Share price
$439.89
Market cap
$152.5B
Price as of
November 13, 2026
FEI Number
3001675293
Address
1266 Kifer Rd, Sunnyvale, California 94086, United States
Country
United States
ID: 2dea1052-5e1b-4f51-b3e3-6792452d36de