Data / Medical devices / Pump, Infusion, Insulin / United States
FDA-registered makers of Pump, Infusion, Insulin in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Pump, Infusion, Insulin (product code LZG). 7 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Pump, Infusion, Insulin
- Product code
- LZG
- Country
- United States
Makers of Pump, Infusion, Insulin 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 | 6 | April 6, 2022 | 0 | 12 | 1 | api.fda.gov |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Complaint file establishment, Specification developer | 6 | October 25, 2016 | 0 | 1 | 1 | api.fda.gov |
| Tandem Diabetes Care, INC. | San Diego, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 6 | October 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Insulet Corporation | Acton, MA, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 2 | April 24, 2023 | 0 | 5 | 2 | api.fda.gov |
| Mannkind Corporation | Danbury, CT, United States | Complaint file establishment, Specification developer | 2 | February 23, 2011 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer | 2 | April 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Modular Medical | San Diego, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | April 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| IntriCon Corporation VH | Vadnais Heights, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diabetes Care, Inc. | Indianapolis, IN, United States | Manufacturer | 0 | 0 | 2 | 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.