Data / Medical devices / Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) / United States
FDA-registered makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) in the United States: 74 establishments
74 establishments in the United States are registered with the FDA to make Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (product code MWI). 43 have a 510(k) clearance or PMA approval on file and 10 have a recall event. FDA data exported November 3, 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
- Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- Product code
- MWI
- Country
- United States
Makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Masimo Corporation | Irvine, CA, United States | Complaint file establishment, Specification developer | 7 | August 12, 2026 | 0 | 0 | 0 | api.fda.gov |
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Specification developer | 7 | September 30, 2021 | 0 | 3 | 0 | api.fda.gov |
| Philips North America LLC | Cambridge, MA, United States | Complaint file establishment, Manufacturer | 6 | January 14, 2022 | 0 | 2 | 0 | api.fda.gov |
| Infinium Medical, Inc. | Largo, FL, United States | Manufacturer | 5 | February 6, 2015 | 0 | 1 | 0 | api.fda.gov |
| Invivo Corporation | Orlando, FL, United States | Specification developer | 5 | September 30, 2021 | 0 | 18 | 0 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Manufacturer, Specification developer | 4 | November 14, 2016 | 0 | 2 | 0 | api.fda.gov |
| Philips North America LLC | Export, PA, United States | Contract manufacturer, Repackager or relabeler | 4 | December 23, 2015 | 0 | 0 | 0 | api.fda.gov |
| Welch Allyn, Inc. | Skaneateles Falls, NY, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | December 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Analog Devices | Wilmington, MA, United States | Complaint file establishment, Manufacturer | 3 | October 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Athena GTX | Johnston, IA, United States | Complaint file establishment, Manufacturer, Remanufacturer | 3 | June 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| AirStrip Technologies, Inc. | San Antonio, TX, United States | Manufacturer | 3 | January 18, 2015 | 0 | 0 | 0 | api.fda.gov |
| Flash Global | Lockbourne, OH, United States | Contract manufacturer, Manufacturer, Remanufacturer, Repackager or relabeler | 3 | August 8, 2018 | 0 | 0 | 0 | api.fda.gov |
| Ge Medical Systems Information Technologies | El Paso, TX, United States | Manufacturer, Repackager or relabeler | 3 | April 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| GE Medical Systems Information Technologies, Inc. | Waukesha, WI, United States | Specification developer | 3 | April 25, 2024 | 0 | 2 | 0 | api.fda.gov |
| GE Medical Systems Information Technologies, Inc. | Wauwatosa, WI, United States | Specification developer | 3 | April 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Iradimed Corporation | Orlando, FL, United States | Manufacturer, Specification developer | 3 | March 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| Dictum Health, Inc. | Malibu, CA, United States | Complaint file establishment, Specification developer | 2 | July 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Etiometry Inc. | Dedham, MA, United States | Manufacturer | 2 | November 25, 2020 | 0 | 0 | 0 | api.fda.gov |
| Hill-Rom, Inc. | Raleigh, NC, United States | Complaint file establishment, Manufacturer | 2 | January 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| LD Technology LLC | Miami, FL, United States | Manufacturer, Repackager or relabeler, Specification developer | 2 | April 27, 2020 | 0 | 0 | 0 | api.fda.gov |
| MINDRAY DS USA, Inc. | Mahwah, NJ, United States | Complaint file establishment, Contract manufacturer | 2 | March 27, 2019 | 0 | 2 | 0 | api.fda.gov |
| Sotera Wireless | Carlsbad, CA, United States | Manufacturer | 2 | December 14, 2015 | 0 | 1 | 0 | api.fda.gov |
| Spacelabs Healthcare Inc. | Snoqualmie, WA, United States | Manufacturer | 2 | September 11, 2019 | 0 | 0 | 0 | api.fda.gov |
| Zoe Medical, Inc. | Topsfield, MA, United States | Manufacturer | 2 | May 8, 2015 | 0 | 0 | 0 | api.fda.gov |
| Advanced Instrumentations, Inc. | Miami, FL, United States | Manufacturer | 1 | February 18, 2014 | 0 | 0 | 0 | api.fda.gov |
| Advanced Monitored Caregiving | New York, NY, United States | Manufacturer | 1 | September 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Aidar Health, Inc | Columbia, MD, United States | Manufacturer, Specification developer | 1 | February 6, 2021 | 0 | 0 | 0 | api.fda.gov |
| Ambient Clinical Analytics | Rochester, MN, United States | Manufacturer | 1 | April 2, 2015 | 0 | 0 | 0 | api.fda.gov |
| Bayer Medical Care Inc. | Indianola, PA, United States | Complaint file establishment, Specification developer | 1 | September 29, 2004 | 0 | 2 | 0 | api.fda.gov |
| Criticare Technologies, Inc. | Warwick, RI, United States | Manufacturer, Repackager or relabeler | 1 | August 1, 2001 | 0 | 0 | 0 | api.fda.gov |
| Digicare Biomedical Technology, Inc. | Boynton Beach, FL, United States | Manufacturer | 1 | September 25, 2019 | 0 | 0 | 0 | api.fda.gov |
| Eko Health, Inc. | Emeryville, CA, United States | Manufacturer | 1 | January 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| Happy Health | Austin, TX, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | September 24, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 1 | May 1, 2012 | 0 | 0 | 0 | api.fda.gov |
| Medwand Solutions, Inc | Rsm, CA, United States | Specification developer | 1 | July 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Medical Informatics Corp. | Houston, TX, United States | Manufacturer | 1 | May 26, 2015 | 0 | 0 | 0 | api.fda.gov |
| Nihon Kohden America, Inc. | Irvine, CA, United States | Complaint file establishment, Manufacturer | 1 | September 16, 2003 | 0 | 0 | 0 | api.fda.gov |
| Ordinatrum Health | Tustin, CA, United States | Manufacturer | 1 | June 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Scimage, Inc. | Los Altos, CA, United States | Repackager or relabeler, Specification developer | 1 | September 8, 2017 | 0 | 0 | 0 | api.fda.gov |
| Talis Clinical LLC | Richfield, OH, United States | Manufacturer | 1 | April 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Unika Health Inc. | Sunnyvale, CA, United States | Specification developer | 1 | February 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Zoll Medical Corporation | Chelmsford, MA, United States | Complaint file establishment, Manufacturer | 1 | March 9, 2021 | 0 | 0 | 0 | api.fda.gov |
| iHealth Labs, Inc. | Sunnyvale, CA, United States | Manufacturer | 1 | February 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Anybattery, Inc | Rosemount, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Axial Medical | Ivyland, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ActiGraph L.L.C. | Pensacola, FL, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avnet, Inc. (Avnet Logistics) | Chandler, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B & G MFG. Co. | Hatfield, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creative Foam Corporation dba MT. OLIVE MFG | Mooresville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EDAN Diagnostics, Inc. | San Diego, CA, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Ever Ppe Inc | Sealy, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| East West Wisconsin | Whitewater, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fabriteq | Knoxville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Oakland, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| First Article Inc | Souderton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flex-Cell Precision, Inc. | Lancaster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Little Ferry, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gamamed Vascular Systems Inc. | Loveland, CO, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gregory MFG., Inc. | Holyoke, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ivy Biomedical Systems, Inc. | Branford, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J & J Precision Technologies, LLC | Lititz, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J&B Precision, Inc. | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Katecho LLC | Des Moines, IA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Solutions Jasper, Inc. | Jasper, IN, 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 | |
| Nimbleheart, Inc. | Sunnyvale, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nortech Systems, Inc. | Milaca, MN, 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 | |
| Nihon Kohden Digital Health Solutions, LLC. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Polyzen, LLC | Apex, NC, 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 | |
| Scottcare Corporation | Cleveland, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sibel Health Inc. | Chicago, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.