Data / Medical devices / Block, Bite / United States
FDA-registered makers of Block, Bite in the United States: 6 establishments
6 establishments in the United States are registered with the FDA to make Block, Bite (product code JXL). 6 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
- Block, Bite
- Product code
- JXL
- Country
- United States
Makers of Block, Bite in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Somatics, LLC | Venice, FL, United States | Complaint file establishment, Specification developer | 2 | October 25, 1999 | 0 | 0 | 0 | api.fda.gov |
| Allied Medical LLC | Earth City, MO, United States | Specification developer | 1 | February 28, 1980 | 0 | 0 | 0 | api.fda.gov |
| GF Health Products, Inc | Atlanta, GA, United States | Specification developer | 1 | February 17, 1989 | 0 | 0 | 0 | api.fda.gov |
| Neurovice | Charlotte, NC, United States | Specification developer | 1 | February 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Manufacturer | 1 | December 9, 1992 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | February 7, 1983 | 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.