Skip to the page
Get started free

Data / Medical devices / Integrated Continuous Glucose Monitoring System, Factory Calibrated

Integrated Continuous Glucose Monitoring System, Factory Calibrated (QBJ): 15 FDA-registered makers in 6 countries

15 establishments in 6 countries are registered with the FDA to make Integrated Continuous Glucose Monitoring System, Factory Calibrated (product code QBJ, Class 2, 21 CFR 862.1355). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on June 8, 2026, and lists 12 recall events (3 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
QBJ
Device class
2
Regulation
862.1355
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States8
Ireland2
Mexico2
United Kingdom1
Malaysia1
China1

Makers of Integrated Continuous Glucose Monitoring System, Factory Calibrated

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
Abbott Diabetes Care Inc.Alameda, CA, United StatesComplaint file establishment, Manufacturer, Specification developer3April 23, 2024000api.fda.gov
Abbott Diabetes Care LimitedWITNEY OXON Oxfordshire, United KingdomManufacturer3April 23, 2024000api.fda.gov
Dexcom, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Specification developer3June 8, 2026093api.fda.gov
Dexcom, Inc.Mesa, AZ, United StatesManufacturer, Manufacturer for export3June 8, 2026000api.fda.gov
Abbott Ireland, ADC KilkennyKilkenny, IrelandManufacturer2April 23, 2024000api.fda.gov
Dexcom International LimitedAthenry Galway(County), IrelandExporter to the US, Manufacturer1June 8, 2026000api.fda.gov
Dexcom (Malaysia) Sdn. Bhd.Bandar Cassia Pulau Pinang, MalaysiaManufacturer1June 8, 2026000api.fda.gov
Flextronics America, LLCAustin, TX, United StatesContract manufacturer0000api.fda.gov
Flextronics International USABuffalo Grove, IL, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Flextronics Manufacturing Aguascalientes, S.A de C.VAguascalientes, MexicoContract manufacturer0000api.fda.gov
Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Isomedix Operations IncEl Paso, TX, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Plexus Corp.Buffalo Grove, IL, United StatesContract manufacturer0000api.fda.gov
Plexus Electronica S. de R.L. de C.V..Zapopan Jalisco, MexicoContract manufacturer0000api.fda.gov
RR Donnelley-Supply Chain SolutionsPlover, WI, United StatesContract manufacturer0000api.fda.gov

Updated June 8, 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.