Data / Medical devices / Outpatient Cardiac Telemetry / United States
FDA-registered makers of Outpatient Cardiac Telemetry in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Outpatient Cardiac Telemetry (product code QYX). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Device
- Outpatient Cardiac Telemetry
- Product code
- QYX
- Country
- United States
Makers of Outpatient Cardiac Telemetry in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Irhythm Technologies, Inc. | San Francisco, CA, United States | Specification developer | 2 | October 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Rhythmedix | Mount Laurel, NJ, United States | Complaint file establishment, Manufacturer | 2 | April 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| iRhythm Technologies, Inc. | Cypress, CA, United States | Manufacturer | 2 | October 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Applied Cardiac Systems, Inc. | Lake Forest, CA, United States | Manufacturer | 1 | August 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| Infobionic, Inc. | Burleson, TX, United States | Complaint file establishment, Specification developer | 1 | March 11, 2016 | 0 | 0 | 0 | api.fda.gov |
| Medtronic, Inc. | Mounds View, MN, United States | Specification developer | 1 | February 6, 2014 | 0 | 0 | 0 | api.fda.gov |
| VivaQuant, Inc | Arden Hills, MN, United States | Manufacturer | 1 | July 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Cardiac Diagnostic Technologies, Inc. | Rochester, MN, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeSignals, Inc. | Milpitas, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.