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Data / Medical devices / Computer, Diagnostic, Pre-Programmed, Single-Function / United States

FDA-registered makers of Computer, Diagnostic, Pre-Programmed, Single-Function in the United States: 19 establishments

19 establishments in the United States are registered with the FDA to make Computer, Diagnostic, Pre-Programmed, Single-Function (product code DXG). 7 have a 510(k) clearance or PMA approval on file and 1 has a recall event. 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.

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Device
Computer, Diagnostic, Pre-Programmed, Single-Function
Product code
DXG
Country
United States

Makers of Computer, Diagnostic, Pre-Programmed, Single-Function in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer3May 22, 2014000api.fda.gov
Caretaker MedicalCharlottesville, VA, United StatesManufacturer1September 26, 2025000api.fda.gov
Draeger Medical Systems, Inc.Andover, MA, United StatesComplaint file establishment, Manufacturer1January 3, 2008000api.fda.gov
Masimo CorporationIrvine, CA, United StatesComplaint file establishment, Specification developer1June 5, 2017000api.fda.gov
Retia Medical Systems IncWhite Plains, NY, United StatesManufacturer, Specification developer1December 13, 2018000api.fda.gov
Seemedx, IncLas Vegas, NV, United StatesSpecification developer1December 8, 1992000api.fda.gov
Transonic Systems, Inc.Ithaca, NY, United StatesManufacturer1January 29, 2015010api.fda.gov
Adm Tronics Unltd, Inc.Northvale, NJ, United StatesContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Centurion Medical Products, LPWilliamston, MI, United StatesSpecification developer0000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer0000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
MINDRAY DS USA, Inc.Mahwah, NJ, United StatesComplaint file establishment, Contract manufacturer0000api.fda.gov
Philips North America LLCCambridge, MA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Philips North America LLCAndover, MA, United StatesSpecification developer0000api.fda.gov
Philips North America LLCMurrysville, PA, United StatesContract manufacturer0000api.fda.gov
Philips North America LLCExport, PA, United StatesContract manufacturer0000api.fda.gov
Repair Operations CenterOak Creek, WI, United StatesRemanufacturer0000api.fda.gov
Spacelabs Healthcare Inc.Snoqualmie, WA, United StatesManufacturer0000api.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.