# Outset Medical, Inc. - Inspection Records

Source: https://www.keypedia.com/companies/outset-medical-inc/f2efc6cd-9155-4428-bb9f-a406c78a50b0

> Inspection records and compliance data for Outset Medical, Inc. in San Jose, California. Access full analysis and detailed observations.

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## Details

- Name: Outset Medical, Inc.
- FEI Number: 3010355846
- City: San Jose
- State: California
- Country Name: United States
- Address Line 1: 3052 Orchard Dr
- Zip Code: 95134

## Related Documents

- [FDA Inspection 1317782 - Outset Medical, Inc. - 2026-07-22](https://www.keypedia.com/records/fda_inspections/outset-medical-inc/435914fd-ad28-462f-ab6f-dafc3f695429) — source: FDA, date: July 22, 2026
- [FDA Inspection 1317782 - Outset Medical, Inc. - 2026-07-22](https://www.keypedia.com/records/fda_inspections/outset-medical-inc/f76609ec-7cd5-4e00-ba8e-3d6feb00afdf) — source: FDA, date: July 22, 2026
- [FDA Inspection 1251442 - Outset Medical, Inc. - 2024-09-18](https://www.keypedia.com/records/fda_inspections/outset-medical-inc/c78978a6-ee14-4321-9a61-ff341b3e85a6) — source: FDA, date: September 18, 2024
- [FDA Inspection 1251442 - Outset Medical, Inc. - 2024-09-18](https://www.keypedia.com/records/fda_inspections/outset-medical-inc/a921f9c9-aaf9-4dae-907c-c5befa7ab810) — classification: Voluntary Action Indicated (VAI), source: FDA, date: September 18, 2024
- [483 - Outset Medical, Inc. - 2023-02-10](https://www.keypedia.com/records/483/outset-medical-inc/1bb76118-b051-4af1-a750-c98076797db1) — source: FDA, date: February 10, 2023
- [WARNING_LETTER - Outset Medical, Inc. - 2023-02-10](https://www.keypedia.com/records/warning_letter/outset-medical-inc/299aab19-a6ab-4333-8a7e-2e2270769ec9) — source: FDA, date: February 10, 2023
- [FDA Inspection 1196985 - Outset Medical, Inc. - 2023-02-10](https://www.keypedia.com/records/fda_inspections/outset-medical-inc/a1c93d1f-fece-4146-b0ee-9f8eca811f3c) — classification: Official Action Indicated (OAI), source: FDA, date: February 10, 2023
- [FDA Inspection 1196985 - Outset Medical, Inc. - 2023-02-10](https://www.keypedia.com/records/fda_inspections/outset-medical-inc/f48f04f6-7177-4134-8044-e2358201a0ad) — classification: Voluntary Action Indicated (VAI), source: FDA, date: February 10, 2023

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## Related Officers

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- [Acting Director](https://www.keypedia.com/people/courtney-h-lias/5e0a64fa-0140-4de2-9eed-929b12def9e9)
- [Program Division Director](https://www.keypedia.com/people/shari-j-shambaugh/aaea1185-eca8-41f8-bec7-d5d0024b582d)
