Data / Medical devices / Vapocoolant Device
Vapocoolant Device (MLY): 12 FDA-registered makers in 3 countries
12 establishments in 3 countries are registered with the FDA to make Vapocoolant Device (product code MLY, Class U). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 25 510(k) clearances under this code, the latest on September 5, 2026, and lists 2 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- MLY
- Device class
- U
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Netherlands | 1 |
| South Korea | 1 |
Makers of Vapocoolant Device
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.
| 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 | |
| Pharmaspray B.V. | VEENDAM Groningen, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Recensmedical Inc. | Hwaseong-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 5, 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.