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Data / Medical devices / System, Thermal Regulating / United States

FDA-registered makers of System, Thermal Regulating in the United States: 31 establishments

31 establishments in the United States are registered with the FDA to make System, Thermal Regulating (product code DWJ). 19 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.

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Device
System, Thermal Regulating
Product code
DWJ
Country
United States

Makers of System, Thermal Regulating in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Augustine Temperature Management, LLCMinnetonka, MN, United StatesManufacturer, Specification developer7April 18, 2024040api.fda.gov
Gentherm Medical, LLCCincinnati, OH, United StatesManufacturer, Specification developer5October 24, 20230150api.fda.gov
Medivance, Inc.Louisville, CO, United StatesSpecification developer5October 24, 2025030api.fda.gov
3T Medical Systems Inc.Edison, NJ, United StatesComplaint file establishment, Specification developer4August 10, 2018000api.fda.gov
CovidienLafayette, CO, United StatesSpecification developer4July 29, 2013000api.fda.gov
Icu Medical, Inc.Lake Forest, IL, United StatesComplaint file establishment, Specification developer4October 28, 2014000api.fda.gov
Solventum Us LLCEagan, MN, United StatesSpecification developer3April 29, 2021000api.fda.gov
Solventum US LLCSan Antonio, TX, United StatesComplaint file establishment, Specification developer3April 29, 2021000api.fda.gov
Adroit Medical Systems, Inc.Loudon, TN, United StatesContract manufacturer, Manufacturer2June 6, 2008000api.fda.gov
Belmont Medical TechnologiesBillerica, MA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export2March 26, 2009020api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer2July 26, 2018000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Specification developer2November 12, 2003000api.fda.gov
Avacore Technologies, Inc.Ann Arbor, MI, United StatesComplaint file establishment, Specification developer1June 22, 2004000api.fda.gov
Encompass Group, LLC.McDonough, GA, United StatesManufacturer, Specification developer1November 12, 2020000api.fda.gov
Hadleigh Health TechnologiesSausalito, CA, United StatesSpecification developer1June 20, 2025000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer1December 1, 2023000api.fda.gov
Steris CorporationMontgomery, AL, United StatesManufacturer1June 13, 2020000api.fda.gov
Solventum US LLCEden Prairie, MN, United StatesManufacturer, Repackager or relabeler1April 24, 2006000api.fda.gov
Xodus Medical, Inc.New Kensington, PA, United StatesManufacturer1April 16, 2026000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Rochester, MN, United StatesContract manufacturer0000api.fda.gov
CDR Manufacturing, Inc., DBA KeytronicOakdale, MN, United StatesContract manufacturer0000api.fda.gov
Creative Foam Corporation dba MT. OLIVE MFGMooresville, IN, United StatesContract manufacturer0000api.fda.gov
Dielectrics, Inc.Chicopee, MA, United StatesContract manufacturer0000api.fda.gov
Dymax, Corp.Zelienople, PA, United StatesContract manufacturer0000api.fda.gov
Humanity Life Extension, LLCSaint Paul, MN, United StatesManufacturer for export0000api.fda.gov
J Sterling Industries LLCKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Minnetronix, Inc.Saint Paul, MN, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Nortech Systems, Inc.Milaca, MN, United StatesContract manufacturer0000api.fda.gov
Uptake Medical Technology Inc.San Jose, CA, United StatesManufacturer for export0000api.fda.gov
ZOLL Circulation, Inc.San Jose, CA, United StatesComplaint file establishment, Manufacturer0000api.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.