Data / Medical devices / Block, Bite
Block, Bite (JXL): 10 FDA-registered makers in 3 countries
10 establishments in 3 countries are registered with the FDA to make Block, Bite (product code JXL, Class 2, 21 CFR 882.5070). 6 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 28 510(k) clearances under this code, the latest on February 22, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- JXL
- Device class
- 2
- Regulation
- 882.5070
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Mexico | 3 |
| China | 1 |
Makers of Block, Bite
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 |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Sion Biotext Mexico, S.A.P.I. De C.V. | Civac Mexico, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sion Biotext Mexico, S.A.P.I. de C.V | Jiutepec Morelos, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical de Mexico, S. de R.L. de C.V. | NUEVO LAREDO Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangdong Honghai Plastics Production Company | Yangjiang City Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 22, 2023. 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.