Data / Medical devices / Vapocoolant Device / United States
FDA-registered makers of Vapocoolant Device in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Vapocoolant Device (product code MLY). 4 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Vapocoolant Device
- Product code
- MLY
- Country
- United States
Makers of Vapocoolant Device in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Gebauer Co. | Cleveland, OH, United States | Complaint file establishment, Manufacturer | 4 | May 7, 2019 | 0 | 2 | 0 | api.fda.gov |
| Vapocoolshot, Inc | Boca Raton, FL, United States | Complaint file establishment, Specification developer | 3 | May 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Nuance Medical, LLC | Carlsbad, CA, United States | Manufacturer, Specification developer | 2 | February 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| 623 Medical | Durham, NC, United States | Complaint file establishment, Specification developer | 1 | December 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Dixon Investments, Inc. | Orchard Hill, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Formulated Solutions, LLC | Largo, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gilero, Inc | Pittsboro, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hubot, Inc. | South Bend, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mueller Sports Medicine, Inc. | Prairie Du Sac, WI, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Tool Engineering, Inc. | West Palm Beach, FL, United States | Contract 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.