Data / Medical devices / Electrode, Electrocardiograph / United States
FDA-registered makers of Electrode, Electrocardiograph in the United States: 50 establishments
50 establishments in the United States are registered with the FDA to make Electrode, Electrocardiograph (product code DRX). 13 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
- Electrode, Electrocardiograph
- Product code
- DRX
- Country
- United States
Makers of Electrode, Electrocardiograph in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Conmed Corporation | Utica, NY, United States | Complaint file establishment, Manufacturer | 12 | August 7, 2009 | 0 | 2 | 0 | api.fda.gov |
| Conmed Corporation | Westborough, MA, United States | Specification developer | 12 | August 7, 2009 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 10 | August 21, 2009 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Andover, MA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 10 | August 21, 2009 | 0 | 0 | 0 | api.fda.gov |
| Multi Biosensors, Inc. | El Paso, TX, United States | Manufacturer | 2 | May 6, 1987 | 0 | 0 | 0 | api.fda.gov |
| Axelgaard MFG. Co., Ltd. | Fallbrook, CA, United States | Manufacturer | 1 | April 13, 2000 | 0 | 0 | 0 | api.fda.gov |
| D. O. Weaver And Company | Aurora, CO, United States | Manufacturer | 1 | February 23, 1989 | 0 | 0 | 0 | api.fda.gov |
| Gereonics, Inc. | Irvine, CA, United States | Manufacturer | 1 | August 6, 1986 | 0 | 0 | 0 | api.fda.gov |
| Kentec Medical, LLC | Irvine, CA, United States | Specification developer | 1 | September 2, 2005 | 0 | 0 | 0 | api.fda.gov |
| LifeSync Corporation | Coral Springs, FL, United States | Manufacturer | 1 | April 15, 1997 | 0 | 0 | 0 | api.fda.gov |
| Med-Dyne | Louisville, KY, United States | Manufacturer | 1 | May 25, 2005 | 0 | 0 | 0 | api.fda.gov |
| Neotech Products, LLC | Valencia, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | January 3, 2002 | 0 | 0 | 0 | api.fda.gov |
| Nimbleheart, Inc. | Sunnyvale, CA, United States | Manufacturer | 1 | August 23, 2017 | 0 | 0 | 0 | api.fda.gov |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Braemar Manufacturing, LLC | Eagan, MN, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Cardiac Diagnostic Technologies, Inc. | Rochester, MN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Braemar Manufacturing, LLC | San Diego, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardionet, LLC | Phoenix, AZ, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardionet, LLC | Linwood, PA, United States | Complaint file establishment, Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CB Innovations, LLC | Carlsbad, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Chicopee, MA, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Hazelwood, MO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health | Wabasha, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cortex, Inc. | Santa Clara, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dictum Health, Inc. | Malibu, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Datex-Ohmeda, Inc. | Wauwatosa, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Datex-Ohmeda, Inc. | Waukesha, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | Buffalo, NY, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 1 | 0 | api.fda.gov | |
| International Biomedical, Ltd. | Austin, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Invivo Corporation | Orlando, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Iradimed Corporation | Orlando, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivy Biomedical Systems, Inc. | Branford, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Johnson Medtech LLC | Vandalia, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LEAD-LOK, INC. d.b.a Nissha Medical Technologies | Sandpoint, ID, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lohmann Precision Die Cutting, LLC | Orange, VA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Med-Linket Corp | Alhambra, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Action Industries, Inc. 306 | Arden, NC, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MG Medical Products LLC | Cincinnati, OH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Peerbridge Health, Inc. | Franklin, TN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Piccolo Medical | San Francisco, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Premier Heart, LLC | Port Washington, NY, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| R & D Medical Products, Inc. | Lake Forest, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum Us LLC | Eagan, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Solventum US LLC | San Antonio, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Taylor Industries, Inc. | Jefferson City, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Electrode Store | Buckley, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zoll Medical Corporation | Chelmsford, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| dms-service llc | Los Angeles, CA, United States | Complaint file establishment, Repackager or relabeler, 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.