Data / Medical devices / Cuff, Nerve / United States
FDA-registered makers of Cuff, Nerve in the United States: 16 establishments
16 establishments in the United States are registered with the FDA to make Cuff, Nerve (product code JXI). 12 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Cuff, Nerve
- Product code
- JXI
- Country
- United States
Makers of Cuff, Nerve in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Alafair Biosciences, Inc. | Austin, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | July 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Biocircuit Technologies | Atlanta, GA, United States | Complaint file establishment, Manufacturer, Specification developer | 3 | April 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Collagen Matrix, Inc. | Oakland, NJ, United States | Manufacturer | 3 | April 3, 2014 | 0 | 0 | 0 | api.fda.gov |
| Cook Biotech, Inc. | West Lafayette, IN, United States | Contract manufacturer, Manufacturer | 3 | October 31, 2016 | 0 | 0 | 0 | api.fda.gov |
| Integra Lifesciences Corporation | Plainsboro, NJ, United States | Manufacturer | 3 | January 6, 2017 | 0 | 1 | 0 | api.fda.gov |
| Integra LifeSciences Corporation | Princeton, NJ, United States | Complaint file establishment, Specification developer | 3 | January 6, 2017 | 0 | 1 | 0 | api.fda.gov |
| Axogen Corporation - Tampa Heights | Tampa, FL, United States | Complaint file establishment, Specification developer | 2 | October 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Integra Neurosciences | Anasco, PR, United States | Manufacturer | 2 | July 16, 2004 | 0 | 0 | 0 | api.fda.gov |
| Celestray Biotech Company, LLC. | Bethesda, MD, United States | Specification developer | 1 | January 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Checkpoint Surgical Inc. | Brecksville, OH, United States | Specification developer | 1 | May 31, 2019 | 0 | 0 | 0 | api.fda.gov |
| Checkpoint Surgical Inc. | Independence, OH, United States | Specification developer | 1 | May 31, 2019 | 0 | 0 | 0 | api.fda.gov |
| SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.) | Birmingham, AL, United States | Manufacturer, Specification developer | 1 | March 22, 1999 | 0 | 0 | 0 | api.fda.gov |
| Allosource | Centennial, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kessel Medical | Vero Beach, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Viant Medical, Inc. | Grand Rapids, MI, 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.