Data / Medical devices / Introducer, Syringe Needle / United States
FDA-registered makers of Introducer, Syringe Needle in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Introducer, Syringe Needle (product code KZH). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Introducer, Syringe Needle
- Product code
- KZH
- Country
- United States
Makers of Introducer, Syringe Needle in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Minimed | Northridge, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | September 22, 2016 | 0 | 0 | 0 | api.fda.gov |
| Ambi, Inc. | Capitola, CA, United States | Manufacturer | 1 | September 4, 1987 | 0 | 0 | 0 | api.fda.gov |
| Emed Technologies Corporation | El Dorado Hills, CA, United States | Specification developer | 1 | October 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boehringer Ingelheim Pharmaceuticals, Inc. | Ridgefield, CT, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insulet Corporation | Acton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sharp Packaging Services, LLC | Macungie, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vapocoolshot, Inc | Boca Raton, FL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.