Medical Device Manufacturer · US , San Jose , CA

Outset Medical, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2016
9
Total
9
Cleared
0
Denied

FDA 510(k) cleared devices by Outset Medical, Inc. Gastroenterology & Urology ✕

9 devices
1-9 of 9
Cleared Jan 26, 2026
Tablo Hemodialysis System (PN-0008000, PN-0006000U)
K253412 · KDI
Gastroenterology & Urology · 118d
Cleared May 03, 2024
Tablo® Hemodialysis System
K232776 · KDI
Gastroenterology & Urology · 235d
Cleared Dec 05, 2023
Tablo® Hemodialysis System
K233335 · KDI
Gastroenterology & Urology · 67d
Cleared Jun 21, 2023
Tablo® Hemodialysis System
K223248 · KDI
Gastroenterology & Urology · 243d
Cleared Jul 29, 2022
Tablo Hemodialysis System
K211370 · KDI
Gastroenterology & Urology · 451d
Cleared Nov 26, 2021
Tablo Cartridge
K210782 · FJK
Gastroenterology & Urology · 255d
Cleared Mar 31, 2020
Tablo Hemodialysis System
K200741 · KDI
Gastroenterology & Urology · 8d
Cleared Dec 12, 2019
Tablo Hemodialysis System, Tablo Cartridge
K190793 · KDI
Gastroenterology & Urology · 259d
Cleared Nov 15, 2016
Tablo Console
K160881 · KDI
Gastroenterology & Urology · 230d
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