Data / Medical devices / United States / Medtronic, Inc.
Medtronic, Inc.: FDA-registered device maker in Tempe, AZ, United States, 3 510(k) clearances
Medtronic, Inc. is registered with the FDA (registration 3004185781) in Tempe, AZ, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 31, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004185781
- Address
- 2343 W. Medtronic Way, Tempe, AZ, United States, 85281
- Owner or operator
- Medtronic, Inc. (2112641)
- Roles
- Manufacturer
- First device listed
- July 8, 2020
- Registered through
- 2026
- Brand names listed
- LINQ II Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor (LNQ22), LINQ Tool Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | MXD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 31, 2023 | K233320 | LINQ II Insertable Cardiac Monitor (LNQ22) | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| May 28, 2021 | K211304 | LINQ II Insertable Cardiac Monitor | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| July 3, 2020 | K200795 | LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit | MXD | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)
- All makers of Medical Device Data System
- All makers of Detector And Alarm, Arrhythmia
Updated October 31, 2023. 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.