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Data / Medical devices / Warmer, Thermal, Infusion Fluid

Warmer, Thermal, Infusion Fluid (LGZ): 46 FDA-registered makers in 13 countries

46 establishments in 13 countries are registered with the FDA to make Warmer, Thermal, Infusion Fluid (product code LGZ, Class 2, 21 CFR 880.5725). 23 of them have a 510(k) clearance or PMA approval on file and 3 have a recall event. The FDA has issued 76 510(k) clearances under this code, the latest on September 18, 2026, and lists 19 recall events (4 Class I). FDA data exported November 2, 2026.

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Product code
LGZ
Device class
2
Regulation
880.5725
Medical specialty
General Hospital

Makers by country

CountryMakers
United States22
Netherlands6
Mexico5
Denmark3
Germany2
Israel1
Italy1
Austria1
Canada1
Belgium1
Nicaragua1
China1
Malaysia1

Makers of Warmer, Thermal, Infusion Fluid

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
Medical Solutions, Inc.Chantilly, VA, United StatesComplaint file establishment, Specification developer7August 12, 2022000api.fda.gov
Quality In Flow Ltd.PETAH TIKVA Central, IsraelManufacturer4December 8, 2022000api.fda.gov
Icu Medical, Inc.Lake Forest, IL, United StatesComplaint file establishment, Specification developer3June 2, 2008000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.Tijuana, B.C. C.P. Baja California, MexicoManufacturer3June 2, 2008000api.fda.gov
Steris CorporationMontgomery, AL, United StatesManufacturer3July 29, 2011000api.fda.gov
Belmont Medical TechnologiesBillerica, MA, United StatesManufacturer2September 2, 2015020api.fda.gov
Mequ A/SCopenhagen Hovedstaden, DenmarkSpecification developer2April 24, 2026000api.fda.gov
Pedigo Products, Inc.Vancouver, WA, United StatesManufacturer2December 6, 2013000api.fda.gov
RAND S.p.A.MEDOLLA Modena, ItalyManufacturer2December 28, 2016010api.fda.gov
Smisson-Cartledge Biomedical LLCMacon, GA, United StatesSpecification developer2August 12, 2022011api.fda.gov
TSC LifeAlmelo Overijssel, NetherlandsManufacturer2November 18, 2025000api.fda.gov
The Surgical Company International B.V.Amsterdam Noord-Holland, NetherlandsSpecification developer2November 18, 2025000api.fda.gov
Biegler GMBHMAUERBACH Niederosterreich, AustriaManufacturer1July 12, 2012000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.APODACA Nuevo Leon, MexicoContract manufacturer, Manufacturer1October 17, 1991000api.fda.gov
Imperial Surgical Ltd.Lachine Quebec, CanadaManufacturer1March 29, 2012000api.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
Stihler Electronic GMBHLeinfelden-Echterdingen Baden-Wurttemberg, GermanyManufacturer1December 18, 2008000api.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
A/S Kurt HansenSvendborg Syddanmark, DenmarkContract manufacturer0000api.fda.gov
Aim B.V.Brunssum Limburg, NetherlandsContract manufacturer0000api.fda.gov
Avances Cientificos de MexicoH. Matamoros Tamaulipas, MexicoContract manufacturer0000api.fda.gov
Beldico S.A.Marche-en-Famenne Luxembourg, BelgiumContract manufacturer0000api.fda.gov
Command Medical Nicaragua SAManagua, NicaraguaContract manufacturer0000api.fda.gov
Dongguan Bao Kang Dian Zi Ke Ji LimitedDongguan City Guangdong, ChinaContract manufacturer0000api.fda.gov
Ecm Europe BVGemert Noord-Brabant, NetherlandsContract manufacturer0000api.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
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Medimexico, S. De R.L. De C.V.TIJUANA Baja California, MexicoContract manufacturer0000api.fda.gov
MFG One, LLCChantilly, VA, United StatesContract manufacturer0000api.fda.gov
Paul E. Danchell A/SJyderup Sjaelland, DenmarkContract manufacturer0000api.fda.gov
PROVITA Medical GmbH & Co. KGWERMELSKIRCHEN North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Spartronics Strongsville, Inc.Strongsville, OH, United StatesContract manufacturer0000api.fda.gov
Steripack Asia Sdn BhdKlang Selangor, MalaysiaContract 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
Unitron Group BVIJzendijke Zeeland, NetherlandsContract manufacturer0000api.fda.gov
Variass Medical Systems BVDrachten Fryslan, NetherlandsContract manufacturer0000api.fda.gov

Updated September 18, 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.