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

FDA-registered makers of Pack, Hot Or Cold, Reusable in the United States: 107 establishments

107 establishments in the United States are registered with the FDA to make Pack, Hot Or Cold, Reusable (product code IME). 0 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, Reusable

Product code

IME

Country

United States

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

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.