Data / Medical devices / Warmer, Infant Radiant / United States
FDA-registered makers of Warmer, Infant Radiant in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Warmer, Infant Radiant (product code FMT). 8 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
- Warmer, Infant Radiant
- Product code
- FMT
- Country
- United States
Makers of Warmer, Infant Radiant in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Datex-Ohmeda, Inc. | Wauwatosa, WI, United States | Specification developer | 9 | March 2, 2022 | 0 | 0 | 0 | api.fda.gov |
| Datex-Ohmeda, Inc. | Waukesha, WI, United States | Specification developer | 9 | March 2, 2022 | 0 | 1 | 1 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 3 | April 2, 2020 | 0 | 1 | 0 | api.fda.gov |
| Draeger Medical Systems, Inc. | Telford, PA, United States | Manufacturer | 3 | January 17, 2025 | 0 | 3 | 0 | api.fda.gov |
| Replacement Parts Industries, Inc. | Simi Valley, CA, United States | Repackager or relabeler, Specification developer | 2 | June 13, 2002 | 0 | 0 | 0 | api.fda.gov |
| Graphic Controls Acquisition Corp.dba Nissha Medical Technologies | Buffalo, NY, United States | Manufacturer | 1 | June 8, 1992 | 0 | 0 | 0 | api.fda.gov |
| International Biomedical, Ltd. | Austin, TX, United States | Manufacturer | 1 | August 17, 2018 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Specification developer | 1 | September 14, 2012 | 0 | 0 | 0 | api.fda.gov |
| Bioseal | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Caf Medical Solutions Inc | Hockley, TX, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Maynardville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RG Medical USA | Mount Juliet, TN, United States | Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tarry Medical Products, Inc. | Danbury, CT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.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.