Data / Medical devices / Splint, Extremity, Inflatable, External / United States
FDA-registered makers of Splint, Extremity, Inflatable, External in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Splint, Extremity, Inflatable, External (product code FZF). 0 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Splint, Extremity, Inflatable, External
- Product code
- FZF
- Country
- United States
Makers of Splint, Extremity, Inflatable, External in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aparata Medical | Orlando, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aspen Surgical Products, Inc. | Caledonia, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Allied Medical LLC | Earth City, MO, United States | Manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Domico Med-Device, LLC | Fenton, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferno-Washington, Inc. | Wilmington, OH, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lu Mark Usa Enterprises Inc | Brea, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 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 | |
| Paradyne Medical Products, Inc | Brea, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Professional Products, Inc. | Defuniak Spgs, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Richardson Products, Inc. | Frankfort, IL, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sun-Scientific Inc. | Dobbs Ferry, NY, United States | Repackager or relabeler, Specification developer | 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.