Data / Medical devices / Catheter, Intracardiac Mapping, High-Density Array / United States
FDA-registered makers of Catheter, Intracardiac Mapping, High-Density Array in the United States: 12 establishments
12 establishments in the United States are registered with the FDA to make Catheter, Intracardiac Mapping, High-Density Array (product code MTD). 6 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Catheter, Intracardiac Mapping, High-Density Array
- Product code
- MTD
- Country
- United States
Makers of Catheter, Intracardiac Mapping, High-Density Array in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Biosense Webster, Inc. | Irvine, CA, United States | Complaint file establishment, Specification developer | 8 | July 10, 2023 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Specification developer | 3 | April 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical, Cardiology Division, Inc. | Plymouth, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | July 9, 2024 | 0 | 1 | 0 | api.fda.gov |
| Cortex, Inc. | Santa Clara, CA, United States | Specification developer | 2 | March 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical | Roseville, MN, United States | Manufacturer | 2 | July 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Sterilmed, Inc. | Plymouth, MN, United States | Reprocessor, Specification developer | 1 | June 23, 2021 | 0 | 0 | 0 | api.fda.gov |
| Greatbatch Medical | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innovative Health, LLC. | Scottsdale, AZ, United States | Reprocessor | 0 | 0 | 0 | 0 | api.fda.gov | |
| Irvine Biomedical. Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Switchback Medical | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Minnetonka, MN, United States | Manufacturer, Reprocessor, 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.