Data / Medical devices / Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) (MXD): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) (product code MXD, Class 2, 21 CFR 870.1025). 9 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 34 510(k) clearances under this code, the latest on August 28, 2026, and lists 7 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- MXD
- Device class
- 2
- Regulation
- 870.1025
- Medical specialty
- Cardiovascular
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Singapore | 1 |
| Germany | 1 |
| Ireland | 1 |
| Switzerland | 1 |
Makers of Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 |
| Medtronic Singapore Operations Pte Ltd | Singapore Central Singapore, Singapore | Manufacturer | 7 | March 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| Biotronik Se & Co. KG | Berlin, Germany | Complaint file establishment, Manufacturer, Repackager or relabeler | 6 | May 19, 2023 | 0 | 0 | 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 |
| Boston Scientific Limited | CLONMEL Tipperary, Ireland | Manufacturer | 4 | September 12, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Europe Sarl | TOLOCHENAZ Vaud, Switzerland | Manufacturer | 4 | July 22, 2021 | 0 | 0 | 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 August 28, 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.