Data / Medical devices / Injector, Pen
Injector, Pen (NSC): 9 FDA-registered makers in 5 countries
9 establishments in 5 countries are registered with the FDA to make Injector, Pen (product code NSC, Class 2, 21 CFR 880.5860). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on January 9, 2007, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NSC
- Device class
- 2
- Regulation
- 880.5860
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 2 |
| Taiwan | 1 |
| Israel | 1 |
| Switzerland | 1 |
Makers of Injector, Pen
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 |
|---|---|---|---|---|---|---|---|---|
| Antares Pharma, Inc. | Minnetonka, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Insulet Corporation | Acton, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaleo, Inc. | Glen Allen, VA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kimball Solutions - Indianapolis | Indianapolis, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Promisemed Hangzhou Meditech Co.,ltd. | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scandinavian Health Ltd. | Taoyuan City, Taiwan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shalon Chemical Industries Ltd. | Kiryat Gat Southern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina | Kunshan Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ypsomed AG | BURGDORF Bern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated January 9, 2007. 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.