Data / Medical devices / Sensor, Glucose, Invasive
Sensor, Glucose, Invasive (MDS): 14 FDA-registered makers in 4 countries
14 establishments in 4 countries are registered with the FDA to make Sensor, Glucose, Invasive (product code MDS, Class 3). 5 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 14 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- MDS
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Ireland | 2 |
| United Kingdom | 1 |
| China | 1 |
Makers of Sensor, Glucose, Invasive
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 |
|---|---|---|---|---|---|---|---|---|
| Medtronic Minimed | Northridge, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 0 | 4 | 9 | 0 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer | 0 | 3 | 0 | 0 | api.fda.gov | |
| Abbott Diabetes Care Inc. | Alameda, CA, United States | Complaint file establishment, Specification developer | 0 | 1 | 2 | 0 | api.fda.gov | |
| Abbott Diabetes Care Limited | WITNEY OXON Oxfordshire, United Kingdom | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Intricon Corporation | Arden Hills, MN, United States | Contract manufacturer, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen Guangdong, China | 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 | |
| IntriCon Corporation VH | Vadnais Heights, 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 | |
| Sanmina Ireland UC | FERMOY, CORK Munster, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, INC. | San Diego, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tech Group Europe Limited t/a West | Mulhaddart Dublin(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The Hibbert Group | Aurora, CO, United States | 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.