Skip to the page
Get started free

Data / Medical devices / Mask, Oxygen, Non-Rebreathing / United States

FDA-registered makers of Mask, Oxygen, Non-Rebreathing in the United States: 18 establishments

18 establishments in the United States are registered with the FDA to make Mask, Oxygen, Non-Rebreathing (product code KGB). 0 have a 510(k) clearance or PMA approval on file and 1 has 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.

Get makers of this device in the United StatesWatch these makers
Device
Mask, Oxygen, Non-Rebreathing
Product code
KGB
Country
United States

Makers of Mask, Oxygen, Non-Rebreathing in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Aniba Health Solutions LLC.Great Neck, NY, United StatesSpecification developer0000api.fda.gov
Allied Medical LLCEarth City, MO, United StatesManufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Bound Tree Medical, LLCGrand Prairie, TX, United StatesManufacturer0000api.fda.gov
Doner Industries, Inc.Rogers, AR, United StatesSpecification developer0000api.fda.gov
Gfa Production IncClearwater, FL, United StatesSpecification developer0000api.fda.gov
Groman Inc.Coconut Creek, FL, United StatesManufacturer, Repackager or relabeler0000api.fda.gov
Hans Rudolph, Inc.Shawnee, KS, United StatesManufacturer0000api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Kemp LLCCharlotte, NC, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Monitored Therapeutics, Inc.Dublin, OH, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Mercury Medical Enterprises, LLCClearwater, FL, United StatesManufacturer0000api.fda.gov
Philips North America LLCBothell, WA, United StatesSpecification developer0000api.fda.gov
Philips North America LLCWoodinville, WA, United StatesSpecification developer0000api.fda.gov
Spiracle TechnologyLos Alamitos, CA, United StatesSpecification developer0000api.fda.gov
Salter LabsEl Paso, TX, United StatesSpecification developer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesComplaint file establishment, Reprocessor, Specification developer0000api.fda.gov
Westmed, Inc.Tucson, AZ, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0010api.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.