Data / Medical devices / Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) / United States
FDA-registered makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) in the United States: 42 establishments
42 establishments in the United States are registered with the FDA to make Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (product code MHX). 27 have a 510(k) clearance or PMA approval on file and 11 have a recall event. FDA data exported November 2, 2026.
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- Device
- Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Product code
- MHX
- Country
- United States
Makers of Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Specification developer | 21 | February 6, 2026 | 0 | 11 | 0 | api.fda.gov |
| Draeger Medical Systems, Inc. | Andover, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 13 | August 20, 2026 | 0 | 13 | 0 | api.fda.gov |
| GE Medical Systems Information Technologies, Inc. | Waukesha, WI, United States | Specification developer | 11 | July 24, 2026 | 0 | 1 | 0 | api.fda.gov |
| GE Medical Systems Information Technologies, Inc. | Wauwatosa, WI, United States | Specification developer | 10 | July 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Manufacturer, Specification developer | 10 | November 5, 2015 | 0 | 29 | 0 | api.fda.gov |
| Fukuda Denshi Usa, Inc. | Redmond, WA, United States | Complaint file establishment, Manufacturer | 8 | March 16, 2015 | 0 | 1 | 0 | api.fda.gov |
| Ge Medical Systems Information Technologies | El Paso, TX, United States | Manufacturer, Repackager or relabeler | 8 | July 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden America, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 7 | July 16, 2021 | 0 | 5 | 0 | api.fda.gov |
| Philips North America LLC | Andover, MA, United States | Manufacturer, Specification developer | 5 | August 6, 2019 | 0 | 37 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer, Manufacturer for export, Specification developer | 4 | December 8, 2017 | 0 | 0 | 0 | api.fda.gov |
| Respironics Novametrix, LLC | Andover, MA, United States | Specification developer | 4 | March 23, 2009 | 0 | 0 | 0 | api.fda.gov |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 3 | July 12, 2022 | 0 | 23 | 0 | api.fda.gov |
| Repair Operations Center | Oak Creek, WI, United States | Remanufacturer | 3 | April 13, 2022 | 0 | 0 | 0 | api.fda.gov |
| AliveCor | Mountain View, CA, United States | Complaint file establishment, Manufacturer | 2 | January 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer | 2 | August 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden Digital Health Solutions, LLC. | Irvine, CA, United States | Manufacturer | 2 | July 29, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sotera Wireless | Carlsbad, CA, United States | Manufacturer | 2 | June 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | September 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| ZOLL Manufacturing Corporation | Pittsburgh, PA, United States | Manufacturer | 2 | December 19, 2019 | 0 | 0 | 0 | api.fda.gov |
| Amco International Manufacturing & Design, Inc. | Brooklyn, NY, United States | Manufacturer | 1 | December 7, 2007 | 0 | 0 | 0 | api.fda.gov |
| Criticare Technologies, Inc. | Warwick, RI, United States | Manufacturer, Repackager or relabeler | 1 | April 17, 2003 | 0 | 1 | 0 | api.fda.gov |
| Ge Healthcare | Chicago, IL, United States | Manufacturer | 1 | December 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 1 | December 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 1 | September 25, 1998 | 0 | 0 | 0 | api.fda.gov |
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Specification developer | 1 | June 1, 2023 | 0 | 1 | 0 | api.fda.gov |
| Pacetech | Clearwater, FL, United States | Manufacturer | 1 | January 30, 1998 | 0 | 0 | 0 | api.fda.gov |
| Parks Medical Electronics, Inc. | Aloha, OR, United States | Manufacturer | 1 | June 2, 1995 | 0 | 0 | 0 | api.fda.gov |
| Anybattery, Inc | Rosemount, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Athena GTX | Johnston, IA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Defibtech Branford | Branford, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EDAN Diagnostics, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hadleigh Health Technologies | Sausalito, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LifeSignals, Inc. | Milpitas, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Murata Vios, Inc. | Woodbury, MN, United States | Complaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nimbleheart, Inc. | Sunnyvale, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natus Neurology Incorporated | Middleton, WI, United States | 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 | |
| VectraCor, Inc. | Totowa, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| VitalConnect, Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Reprocessor | 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.