FDA establishment 3010355846, San Jose, California, United States. Part of Outset Medical's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
FY2018 to FY2027 to date; 1 classified OAI
A hatched bar is a year that is not over, so its count covers only part of the year.
Inspections citing each reference
| Sep 18, 2024 | Devices · Compliance: Devices | None posted | Voluntary Action Indicated (VAI) |
| Feb 10, 2023 | Devices · Compliance: DevicesDevices · Postmarket Assurance: Devices | 4 cited references
| Official Action Indicated (OAI) |
| Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tablo Hemodialysis…Device · Z-0019-2025 | Class II | Aug 1, 2024 |
| TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578…Device · Z-2150-2024 | Class II | Apr 30, 2024 |
| Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001Device · Z-1485-2024 | Class I | Mar 6, 2024 |
| Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-contained…Device · Z-1351-2023 | Class II | Jan 24, 2023 |
| Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000Device · Z-0813-2022 | Class II | Jan 20, 2022 |
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard, warning letters and enforcement reports
San Jose, California, United States. Part of