Skip to the page

Data / Medical devices / Calculator, Drug Dose

Calculator, Drug Dose (NDC): 28 FDA-registered makers in 9 countries

28 establishments in 9 countries are registered with the FDA to make Calculator, Drug Dose (product code NDC, Class 2, 21 CFR 868.1890). 12 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 56 510(k) clearances under this code, the latest on October 5, 2026, and lists 14 recall events (0 Class I). 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.

Product code
NDC
Device class
2
Regulation
868.1890
Medical specialty
Anesthesiology

Makers by country

CountryMakers
United States20
France1
Switzerland1
Spain1
Poland1
Israel1
Mexico1
China1
Taiwan1

Makers of Calculator, Drug Dose

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic MinimedNorthridge, CA, United StatesComplaint file establishment, Manufacturer, Specification developer6January 8, 2026040api.fda.gov
Glytec, LLCGreenville, SC, United StatesManufacturer4May 27, 2026000api.fda.gov
Monarch Medical TechnologiesCharlotte, NC, United StatesComplaint file establishment, Manufacturer4December 11, 2024020api.fda.gov
VoluntisRueil-Malmaison Hauts-de-Seine, FranceManufacturer3November 7, 2017010api.fda.gov
Amalgam Rx, IncWilmington, DE, United StatesManufacturer2August 21, 2024000api.fda.gov
WelldocColumbia, MD, United StatesManufacturer2July 28, 2023000api.fda.gov
Comerge AGZurich, SwitzerlandManufacturer1August 20, 2025000api.fda.gov
Medical Decision NetworkCharlottesville, VA, United StatesManufacturer1September 15, 2014000api.fda.gov
Pronia Medical SystemsLewisburg, PA, United StatesManufacturer1August 21, 2008000api.fda.gov
Picis Clinical Solutions, Inc.Peabody, MA, United StatesComplaint file establishment, Manufacturer1August 27, 2012000api.fda.gov
Picis Clinical Solutions, S.A.U.Barcelona, SpainManufacturer1August 27, 2012000api.fda.gov
UpdocMountain View, CA, United StatesManufacturer, Specification developer1December 23, 2025000api.fda.gov
Biointellisense Inc.Redwood City, CA, United StatesSpecification developer0000api.fda.gov
Clinico Medical Sp. z o.o.Blonie/Miekinia Dolnoslaskie, PolandContract manufacturer0000api.fda.gov
Deka Research & Development Corp.Manchester, NH, United StatesSpecification developer0000api.fda.gov
Dreamed Diabetes LtdPetah Tikva Tel Aviv, IsraelComplaint file establishment, Manufacturer0000api.fda.gov
Insulet CorporationActon, MA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Medtronic Puerto Rico Operations Co., JuncosJuncos, PR, United StatesManufacturer0000api.fda.gov
Merrimack ManufacturingManchester, NH, United StatesContract manufacturer0000api.fda.gov
Millyard Advanced Medical Products LLCManchester, NH, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Merrimack ManufacturingManchester, NH, United StatesContract manufacturer0000api.fda.gov
NPA de Mexico S.de R.L. de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Roche Diabetes Care, Inc.Indianapolis, IN, United StatesManufacturer0060api.fda.gov
SanminaKunshan Jiangsu, ChinaContract manufacturer0000api.fda.gov
Tandem Diabetes Care, Inc.San Diego, CA, United StatesManufacturer, Remanufacturer0000api.fda.gov
Tandem Diabetes Care, Inc.San Diego, CA, United StatesManufacturer for export0000api.fda.gov
Tandem Diabetes Care, INC.San Diego, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Wistron Medical Technology CorporationZhubei City Hsinchu(County), TaiwanContract manufacturer0000api.fda.gov

Updated October 5, 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.