Data / Medical devices / Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)
Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) (MXC): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) (product code MXC, Class 2, 21 CFR 870.2800). 3 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on May 17, 2023, and lists 4 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- MXC
- Device class
- 2
- Regulation
- 870.2800
- Medical specialty
- Cardiovascular
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Malaysia | 1 |
Makers of Recorder, Event, Implantable Cardiac, (Without 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 |
|---|---|---|---|---|---|---|---|---|
| Abbott Medical | Sylmar, CA, United States | Manufacturer, Specification developer | 15 | May 17, 2023 | 0 | 4 | 0 | api.fda.gov |
| Abbott Medical | Penang Pulau Pinang, Malaysia | Manufacturer | 5 | May 17, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medtronic, Inc. | Mounds View, MN, United States | Specification developer | 1 | January 21, 2000 | 0 | 0 | 0 | api.fda.gov |
| Cadence Device, Inc. | Cranberry Township, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| JunoPacific, Inc. | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 17, 2023. 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.