Data / Medical devices / Automated Insulin Dosing Device System, Single Hormonal Control / United States
FDA-registered makers of Automated Insulin Dosing Device System, Single Hormonal Control in the United States: 8 establishments
8 establishments in the United States are registered with the FDA to make Automated Insulin Dosing Device System, Single Hormonal Control (product code OZP). 5 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Automated Insulin Dosing Device System, Single Hormonal Control
- Product code
- OZP
- Country
- United States
Makers of Automated Insulin Dosing Device System, Single Hormonal Control in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ascensia Diabetes Care US Inc. | Parsippany, NJ, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Ascensia Diabetes Care US Inc. | Valhalla, NY, United States | Complaint file establishment, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Minimed | Northridge, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 0 | 1 | 13 | 2 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer, Manufacturer for export, Repackager or relabeler | 0 | 1 | 0 | 0 | api.fda.gov | |
| Roche Diabetes Care, Inc. | Indianapolis, IN, United States | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Intricon Corporation | Arden Hills, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IntriCon Corporation Grey Fox | Arden Hills, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RR Donnelley-Supply Chain Solutions | Plover, WI, United States | Contract 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.