Data / Medical devices / Electrocardiograph / United States
FDA-registered makers of Electrocardiograph in the United States: 55 establishments
55 establishments in the United States are registered with the FDA to make Electrocardiograph (product code DPS). 30 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.
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- Device
- Electrocardiograph
- Product code
- DPS
- Country
- United States
Makers of Electrocardiograph in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Manufacturer, Specification developer | 8 | January 6, 2016 | 0 | 0 | 0 | api.fda.gov |
| GE Medical Systems Information Technologies, Inc. | Wauwatosa, WI, United States | Manufacturer, Specification developer | 7 | January 26, 2026 | 0 | 1 | 0 | api.fda.gov |
| GE Medical Systems Information Technologies, Inc. | Waukesha, WI, United States | Specification developer | 4 | January 26, 2026 | 0 | 0 | 0 | api.fda.gov |
| AliveCor | Mountain View, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | June 7, 2024 | 0 | 0 | 0 | api.fda.gov |
| Prolaio Inc. | Chicago, IL, United States | Manufacturer | 3 | June 11, 2020 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Specification developer | 3 | June 30, 2021 | 0 | 1 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer, Manufacturer for export, Specification developer | 2 | August 24, 2011 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Andover, MA, United States | Specification developer | 2 | May 9, 2008 | 0 | 5 | 0 | api.fda.gov |
| VectraCor, Inc. | Totowa, NJ, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 2 | August 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| Accurkardia Inc. | New York, NY, United States | Manufacturer | 1 | December 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Anybattery, Inc | Rosemount, MN, United States | Manufacturer | 1 | May 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Applied Cardiac Systems, Inc. | Lake Forest, CA, United States | Manufacturer | 1 | March 11, 1986 | 0 | 0 | 0 | api.fda.gov |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer | 1 | March 25, 2022 | 0 | 0 | 0 | api.fda.gov |
| Cardiac Insight, Inc. | Bellevue, WA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | February 5, 2013 | 0 | 0 | 0 | api.fda.gov |
| Fondcircle Inc. | Newport Beach, CA, United States | Specification developer | 1 | May 30, 2017 | 0 | 0 | 0 | api.fda.gov |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 1 | March 5, 2014 | 0 | 0 | 0 | api.fda.gov |
| Imedrix Diagnostics Corporation | Chester, NJ, United States | Specification developer | 1 | January 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Infinium Medical, Inc. | Largo, FL, United States | Manufacturer, Repackager or relabeler | 1 | April 25, 2012 | 0 | 0 | 0 | api.fda.gov |
| Inmedix, Inc. | Normandy Park, WA, United States | Specification developer | 1 | January 16, 2025 | 0 | 0 | 0 | api.fda.gov |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | April 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medtronic, Inc. | Mounds View, MN, United States | Manufacturer | 1 | May 29, 2003 | 0 | 2 | 0 | api.fda.gov |
| Midmark Corp. | Blue Ash, OH, United States | Specification developer | 1 | March 22, 2011 | 0 | 0 | 0 | api.fda.gov |
| Midmark Corporation | Versailles, OH, United States | Manufacturer | 1 | March 22, 2011 | 0 | 1 | 0 | api.fda.gov |
| MPSC | Charlottesville, VA, United States | Manufacturer | 1 | February 28, 2018 | 0 | 0 | 0 | api.fda.gov |
| Nasiff Assoc., Inc. | Central Square, NY, United States | Contract manufacturer, Manufacturer | 1 | July 9, 1992 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden America, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 1 | August 30, 2007 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden America Fulfillment Center | Foothill Ranch, CA, United States | Manufacturer | 1 | August 30, 2007 | 0 | 0 | 0 | api.fda.gov |
| Spaulding Medical, LLC | Menomonee Falls, WI, United States | Manufacturer | 1 | August 12, 2015 | 0 | 0 | 0 | api.fda.gov |
| Zbeats, Inc | Stony Brook, NY, United States | Complaint file establishment, Manufacturer | 1 | July 10, 2025 | 0 | 0 | 0 | api.fda.gov |
| ZOLL Manufacturing Corporation | Pittsburgh, PA, United States | Manufacturer | 1 | January 28, 2019 | 0 | 0 | 0 | api.fda.gov |
| Aidar Health, Inc | Columbia, MD, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Analog Devices | Wilmington, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Athena GTX | Johnston, IA, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CDR Manufacturing, Inc., DBA Keytronic | Oakdale, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirtec Medical | Enfield, CT, United States | Contract manufacturer | 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 | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Echonous, Inc. | Redmond, WA, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EDAN Diagnostics, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eko Health, Inc. | Emeryville, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Heartbeam | Santa Clara, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NextPhase Medical Devices, LLC | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ontogen Manufacturing LLC | Lisle, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Murrysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips North America LLC | Export, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respironics Novametrix, LLC | Andover, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RR Donnelley-Supply Chain Solutions | Plover, WI, United States | Contract manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Safebeat RX Inc. | San Francisco, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Twin River Group | Trenton, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zoe Medical, Inc. | Topsfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zoll Medical Corporation | Chelmsford, MA, United States | Complaint file establishment, Manufacturer | 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.