iRhythm Technologies, Inc. - FDA 510(k) Cleared Devices
17
Total
17
Cleared
0
Denied
iRhythm Technologies, Inc. has 17 FDA 510(k) cleared cardiovascular devices. Based in San Francisco, US.
Latest FDA clearance: Aug 2025. Active since 2008.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
17 devices
Cleared
Aug 15, 2025
Zio® monitor (DFG0001)
Cardiovascular
262d
Cleared
Oct 30, 2024
Zio AT® device (A100A1001)
Cardiovascular
281d
Cleared
Oct 21, 2024
Zio AT® device (A100A1001)
Cardiovascular
291d
Cleared
Feb 15, 2023
ZEUS System
Cardiovascular
191d
Cleared
Jul 19, 2022
ZEUS System (Zio Watch)
Cardiovascular
273d
Cleared
May 21, 2021
Zio Monitor
Cardiovascular
275d
Cleared
May 21, 2021
Zio ECG Utilization Software (ZEUS) System
Cardiovascular
262d
Cleared
Aug 23, 2019
Zio XT ECG Monitoring System, Zio AT ECG Monitoring System
Cardiovascular
169d
Cleared
Aug 29, 2018
Zio AT ECG Monitoring System, ZEUS System
Cardiovascular
83d
Cleared
Jun 02, 2017
Zio AT ECG Monitoring System
Cardiovascular
169d
Cleared
Jun 19, 2015
ZIO SR ECG Monitoring Service
Cardiovascular
190d
Cleared
Nov 21, 2014
ZEUS (ZIO ECG Utilization Service) System
Cardiovascular
63d