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Data / Medical devices / Pack, Hot Or Cold, Disposable / United States

FDA-registered makers of Pack, Hot Or Cold, Disposable in the United States: 57 establishments

57 establishments in the United States are registered with the FDA to make Pack, Hot Or Cold, Disposable (product code IMD). 6 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Pack, Hot Or Cold, Disposable
Product code
IMD
Country
United States

Makers of Pack, Hot Or Cold, Disposable in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Coopersurgical, Inc.Trumbull, CT, United StatesSpecification developer2February 3, 1994030api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesManufacturer1May 2, 1994000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer1February 26, 1998000api.fda.gov
International Biomedical, Ltd.Austin, TX, United StatesManufacturer1October 6, 2022000api.fda.gov
Pristech Products, Inc.San Antonio, TX, United StatesContract manufacturer, Manufacturer, Repackager or relabeler1February 3, 1994000api.fda.gov
Rapid Aid Corp.Moberly, MO, United StatesManufacturer1July 24, 2017000api.fda.gov
American Hospital SupplySanta Monica, CA, United StatesSpecification developer0000api.fda.gov
Aspen Surgical Products, Inc.Caledonia, MI, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Angelini Pharma Inc.Albany, GA, United StatesContract manufacturer, Manufacturer, Manufacturer for export0010api.fda.gov
Beekley CorporationBristol, CT, United StatesManufacturer0000api.fda.gov
Bridges Consumer HealthcareChattanooga, TN, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Coldstar International IncBristol, TN, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Coldventures LLCConshohocken, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Cool Comforts LLCCincinnati, OH, United StatesSpecification developer0000api.fda.gov
CPM SolutionsSouth Windsor, CT, United StatesContract manufacturer0000api.fda.gov
CorneaCare IncPhiladelphia, PA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Deroyal Industries, Inc.New Tazewell, TN, United StatesContract manufacturer, Repackager or relabeler0000api.fda.gov
Dicks Sporting Goods IncCoraopolis, PA, United StatesSpecification developer0000api.fda.gov
Djo, LLCCarlsbad, CA, United StatesSpecification developer0000api.fda.gov
Drmenta,incAlbany, NY, United StatesManufacturer for export0000api.fda.gov
Dukal LLCRonkonkoma, NY, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Enduring Brands LLCAustin, TX, United StatesSpecification developer0000api.fda.gov
Gfa Production IncClearwater, FL, United StatesSpecification developer0000api.fda.gov
Implus Footcare LLCDurham, NC, United StatesSpecification developer0000api.fda.gov
JosNoe Medical IncNixa, MO, United StatesSpecification developer0000api.fda.gov
Kinetec UsaJackson, WI, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Kobayashi America Manufacturing, LLCDalton, GA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Kenvue Brands LLCSummit, NJ, United StatesSpecification developer0000api.fda.gov
Life Wear Technologies, Inc.Pompano Beach, FL, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Lifeline First Aid LLCLake Oswego, OR, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Medi-Temp LLC.Peoria, AZ, United StatesManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Mueller Sports Medicine, Inc.Prairie Du Sac, WI, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
MedlogixRussia, OH, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Ncap Medical IncHeber City, UT, United StatesManufacturer0000api.fda.gov
Nortech Laboratories, Inc.E Farmingdale, NY, United StatesContract manufacturer, Manufacturer0000api.fda.gov
O&M Halyard, Inc.Alpharetta, GA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Onlycare IncDenver, CO, United StatesManufacturer0000api.fda.gov
Orthocor Medical Inc.Blaine, MN, United StatesManufacturer0000api.fda.gov
Oasis Medical, Inc.Glendora, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Pain Relief TechnologiesSandy, UT, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Pixie Cup LLCWalnut Shade, MO, United StatesSpecification developer0000api.fda.gov
Pain Care LabsAtlanta, GA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
R & D Medical Products, Inc.Lake Forest, CA, United StatesContract manufacturer0000api.fda.gov
Rain Eye Drops LLCWilmington, DE, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Ready Set ImportBeverly Hills, CA, United StatesSpecification developer0000api.fda.gov
Rael, Inc.Buena Park, CA, United StatesSpecification developer0000api.fda.gov
Safeguard Us Operating, LLCHuntersville, NC, United StatesRepackager or relabeler, Specification developer0010api.fda.gov
Sunbeam Products, Inc.Atlanta, GA, United StatesManufacturer, Specification developer0000api.fda.gov
Shock Doctor, Inc.Costa Mesa, CA, United StatesSpecification developer0000api.fda.gov
Tacmed Solutions, LLCAnderson, SC, United StatesSpecification developer0000api.fda.gov
Talbot's Pharmaceuticals Family Products LLCMonroe, LA, United StatesRepackager or relabeler, Specification developer0000api.fda.gov
Techtrade LLCOrlando, FL, United StatesManufacturer, Specification developer0000api.fda.gov
The Hygenic Company, LLCAkron, OH, United StatesSpecification developer0000api.fda.gov
The Mentholatum CompanyOrchard Park, NY, United StatesComplaint file establishment, Repackager or relabeler, Specification developer0000api.fda.gov
Trademark Plastics Inc.Riverside, CA, United StatesSpecification developer0000api.fda.gov
Welly Health PBCMinneapolis, MN, United StatesSpecification developer0000api.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.