Data / Medical devices / Calculator, Drug Dose / United States
FDA-registered makers of Calculator, Drug Dose in the United States: 20 establishments
20 establishments in the United States are registered with the FDA to make Calculator, Drug Dose (product code NDC). 9 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.
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- Calculator, Drug Dose
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- United States
Makers of Calculator, Drug Dose in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Minimed | Northridge, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 6 | January 8, 2026 | 0 | 4 | 0 | api.fda.gov |
| Glytec, LLC | Greenville, SC, United States | Manufacturer | 4 | May 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Monarch Medical Technologies | Charlotte, NC, United States | Complaint file establishment, Manufacturer | 4 | December 11, 2024 | 0 | 2 | 0 | api.fda.gov |
| Amalgam Rx, Inc | Wilmington, DE, United States | Manufacturer | 2 | August 21, 2024 | 0 | 0 | 0 | api.fda.gov |
| Welldoc | Columbia, MD, United States | Manufacturer | 2 | July 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medical Decision Network | Charlottesville, VA, United States | Manufacturer | 1 | September 15, 2014 | 0 | 0 | 0 | api.fda.gov |
| Pronia Medical Systems | Lewisburg, PA, United States | Manufacturer | 1 | August 21, 2008 | 0 | 0 | 0 | api.fda.gov |
| Picis Clinical Solutions, Inc. | Peabody, MA, United States | Complaint file establishment, Manufacturer | 1 | August 27, 2012 | 0 | 0 | 0 | api.fda.gov |
| Updoc | Mountain View, CA, United States | Manufacturer, Specification developer | 1 | December 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Biointellisense Inc. | Redwood City, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deka Research & Development Corp. | Manchester, NH, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insulet Corporation | Acton, MA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merrimack Manufacturing | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millyard Advanced Medical Products LLC | Manchester, NH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merrimack Manufacturing | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diabetes Care, Inc. | Indianapolis, IN, United States | Manufacturer | 0 | 0 | 6 | 0 | api.fda.gov | |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, INC. | San Diego, CA, United States | Complaint file establishment, 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.