Skip to the page

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.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Device
Electrode, Electrocardiograph
Product code
DRX
Country
United States

Makers of Electrode, Electrocardiograph in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer12August 7, 2009020api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer12August 7, 2009000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer10August 21, 2009000api.fda.gov
Philips North America LLCAndover, MA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer10August 21, 2009000api.fda.gov
Multi Biosensors, Inc.El Paso, TX, United StatesManufacturer2May 6, 1987000api.fda.gov
Axelgaard MFG. Co., Ltd.Fallbrook, CA, United StatesManufacturer1April 13, 2000000api.fda.gov
D. O. Weaver And CompanyAurora, CO, United StatesManufacturer1February 23, 1989000api.fda.gov
Gereonics, Inc.Irvine, CA, United StatesManufacturer1August 6, 1986000api.fda.gov
Kentec Medical, LLCIrvine, CA, United StatesSpecification developer1September 2, 2005000api.fda.gov
LifeSync CorporationCoral Springs, FL, United StatesManufacturer1April 15, 1997000api.fda.gov
Med-DyneLouisville, KY, United StatesManufacturer1May 25, 2005000api.fda.gov
Neotech Products, LLCValencia, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1January 3, 2002000api.fda.gov
Nimbleheart, Inc.Sunnyvale, CA, United StatesManufacturer1August 23, 2017000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Braemar Manufacturing, LLCEagan, MN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Boston Scientific Cardiac Diagnostic Technologies, Inc.Rochester, MN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Braemar Manufacturing, LLCSan Diego, CA, United StatesSpecification developer0000api.fda.gov
Cardionet, LLCPhoenix, AZ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Cardionet, LLCLinwood, PA, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
CB Innovations, LLCCarlsbad, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Cardinal HealthChicopee, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer0000api.fda.gov
Cardinal HealthWabasha, MN, United StatesManufacturer0000api.fda.gov
Cortex, Inc.Santa Clara, CA, United StatesSpecification developer0000api.fda.gov
Dictum Health, Inc.Malibu, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesManufacturer0000api.fda.gov
Datex-Ohmeda, Inc.Wauwatosa, WI, United StatesSpecification developer0000api.fda.gov
Datex-Ohmeda, Inc.Waukesha, WI, United StatesSpecification developer0000api.fda.gov
Graphic Controls Acquisition Corp.dba Nissha Medical TechnologiesBuffalo, NY, United StatesContract manufacturer, Manufacturer, Specification developer0010api.fda.gov
International Biomedical, Ltd.Austin, TX, United StatesManufacturer0000api.fda.gov
Invivo CorporationOrlando, FL, United StatesSpecification developer0000api.fda.gov
Iradimed CorporationOrlando, FL, United StatesManufacturer0000api.fda.gov
Ivy Biomedical Systems, Inc.Branford, CT, United StatesManufacturer0000api.fda.gov
Johnson Medtech LLCVandalia, OH, United StatesContract manufacturer0000api.fda.gov
LEAD-LOK, INC. d.b.a Nissha Medical TechnologiesSandpoint, ID, United StatesContract manufacturer0000api.fda.gov
Lohmann Precision Die Cutting, LLCOrange, VA, United StatesContract manufacturer0000api.fda.gov
Med-Linket CorpAlhambra, CA, United StatesManufacturer0000api.fda.gov
Medical Action Industries, Inc. 306Arden, NC, United StatesContract manufacturer, Manufacturer, Repackager or relabeler0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
MG Medical Products LLCCincinnati, OH, United StatesSpecification developer0000api.fda.gov
Peerbridge Health, Inc.Franklin, TN, United StatesSpecification developer0000api.fda.gov
Piccolo MedicalSan Francisco, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Premier Heart, LLCPort Washington, NY, United StatesManufacturer, Specification developer0000api.fda.gov
R & D Medical Products, Inc.Lake Forest, CA, United StatesContract manufacturer0000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer0000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Taylor Industries, Inc.Jefferson City, MO, United StatesContract manufacturer0000api.fda.gov
The Electrode StoreBuckley, WA, United StatesManufacturer0000api.fda.gov
Zoll Medical CorporationChelmsford, MA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
dms-service llcLos Angeles, CA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.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.