Data / Medical devices / Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) / United States
FDA-registered makers of Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) (product code MXD). 5 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- Product code
- MXD
- Country
- United States
Makers of Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic, Inc. | Mounds View, MN, United States | Manufacturer, Specification developer | 14 | March 28, 2024 | 0 | 4 | 0 | api.fda.gov |
| Boston Scientific Corporation | Saint Paul, MN, United States | Manufacturer, Specification developer | 4 | September 12, 2025 | 0 | 3 | 0 | api.fda.gov |
| Medtronic, Inc. | Tempe, AZ, United States | Manufacturer | 3 | October 31, 2023 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Sylmar, CA, United States | Manufacturer | 2 | December 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medtronic, Inc. | Minneapolis, MN, United States | Manufacturer | 2 | July 3, 2020 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.