FDA Inspection 1317782 - Outset Medical, Inc. - July 22, 2026

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Record Details

This FDA Inspection record concerns Outset Medical, Inc., with an inspection on July 22, 2026, issued by the San Francisco District Office, covering medical devices & rad health.

Company: Outset Medical, Inc.
Inspection Date: July 22, 2026
Product Type: Medical Devices & Rad Health
Office: San Francisco District Office

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ID · f76609ec-7cd5-4e00-ba8e-3d6feb00afdf

Violation Codes7

21 CFR 803.50(a)(2)21 CFR 803.56ISO 13485:2016 Clause 4.1.5ISO 13485:2016 Clause 7.3.9ISO 13485:2016 Clause 8.2.2ISO 13485:2016 Clause 8.4ISO 13485:2016 Clause 8.5.2

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FDA Inspection

Outset Medical, Inc.July 22, 2026