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Data / Medical devices / Warmer, Thermal, Infusion Fluid / United States

FDA-registered makers of Warmer, Thermal, Infusion Fluid in the United States: 22 establishments

22 establishments in the United States are registered with the FDA to make Warmer, Thermal, Infusion Fluid (product code LGZ). 13 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.

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Device
Warmer, Thermal, Infusion Fluid
Product code
LGZ
Country
United States

Makers of Warmer, Thermal, Infusion Fluid in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medical Solutions, Inc.Chantilly, VA, United StatesComplaint file establishment, Specification developer7August 12, 2022000api.fda.gov
Icu Medical, Inc.Lake Forest, IL, United StatesComplaint file establishment, Specification developer3June 2, 2008000api.fda.gov
Steris CorporationMontgomery, AL, United StatesManufacturer3July 29, 2011000api.fda.gov
Belmont Medical TechnologiesBillerica, MA, United StatesManufacturer2September 2, 2015020api.fda.gov
Pedigo Products, Inc.Vancouver, WA, United StatesManufacturer2December 6, 2013000api.fda.gov
Smisson-Cartledge Biomedical LLCMacon, GA, United StatesSpecification developer2August 12, 2022011api.fda.gov
Mac MedicalMillstadt, IL, United StatesContract manufacturer, Manufacturer1March 5, 2019000api.fda.gov
Medela LLCMchenry, IL, United StatesManufacturer1June 13, 2013000api.fda.gov
Nxstage Medical, Inc.Lawrence, MA, United StatesComplaint file establishment, Specification developer1October 24, 2001000api.fda.gov
Smithworks, Inc.Lindale, TX, United StatesManufacturer, Remanufacturer1December 22, 2006000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer1June 26, 2006000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer1June 26, 2006000api.fda.gov
Solventum US LLCEden Prairie, MN, United StatesManufacturer1June 26, 2006000api.fda.gov
Enercon TechnologiesGray, ME, United StatesContract manufacturer0000api.fda.gov
Estill Medical Technologies, Inc.Dallas, TX, United StatesSpecification developer0000api.fda.gov
Garrett Heilbrun Technology Partners, LLC Dba Cobalt Product SolutionsPlano, TX, United StatesContract manufacturer0000api.fda.gov
MFG One, LLCChantilly, VA, United StatesContract manufacturer0000api.fda.gov
Spartronics Strongsville, Inc.Strongsville, OH, United StatesContract manufacturer0000api.fda.gov
STRYKER Communications, Inc.Flower Mound, TX, United StatesManufacturer0000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
SunMed Group Holdings, LLCGrand Rapids, MI, United StatesContract manufacturer0000api.fda.gov
Thermedx, LLCSolon, OH, United StatesComplaint file establishment, Manufacturer0000api.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.