Data / Medical devices / On-Body Injector / United States
FDA-registered makers of On-Body Injector in the United States: 5 establishments
5 establishments in the United States are registered with the FDA to make On-Body Injector (product code QLF). 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
- On-Body Injector
- Product code
- QLF
- Country
- United States
Makers of On-Body Injector in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| A+ Secure Packaging | La Vergne, TN, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| AbbVie Inc. | Tempe, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Apellis | Waltham, MA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enable Injections Inc | Cincinnati, OH, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Enable Injections Inc | Cincinnati, OH, United States | 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.