Data / Medical devices / Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (OYC): 5 FDA-registered makers in 1 country
5 establishments in 1 country are registered with the FDA to make Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor (product code OYC, Class 3). 2 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 11 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- OYC
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
Makers of Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
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 |
|---|---|---|---|---|---|---|---|---|
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Complaint file establishment, Specification developer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Tandem Diabetes Care, INC. | San Diego, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 1 | 0 | 0 | api.fda.gov | |
| Intricon Corporation | Arden Hills, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Minimed | Northridge, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 0 | 0 | 9 | 1 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer, Manufacturer for export | 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.