Outset Medical, Inc.
4 FDA 510(k) clearances · Recalling firm
| Record | Firm | Date |
|---|---|---|
| Tablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The Tab recall (Z-0019-2025) | Outset Medical, Inc. | 2024-10-03 |
| TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN recall (Z-2150-2024) | Outset Medical, Inc. | 2024-06-14 |
| Tablo Hemodialysis System, REF: PN-0003000, PN-0006000 and PN-0007001 recall (Z-1485-2024) | Outset Medical, Inc. | 2024-04-12 |
| Outset Tablo Model Numbers (REF): PN-0006000 PN-0007001 Tablo is a next generation, self-c recall (Z-1351-2023) | Outset Medical, Inc. | 2023-04-07 |
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Every clearance here is in the API, with alerts when new ones post.