Data / Medical devices / United States / Eagle Electrode Manufacturing, LLC
Eagle Electrode Manufacturing, LLC: FDA-registered device maker in Ijamsville, MD, United States, 1 510(k) clearance
Eagle Electrode Manufacturing, LLC is registered with the FDA (registration 3009492424) in Ijamsville, MD, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 11, 2003. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009492424
- Address
- 10075 Tyler Place Suite 11, Ijamsville, MD, United States, 21754
- Owner or operator
- Eagle Electrode Manufacturing, LLC (10040002)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- February 29, 2012
- Registered through
- 2026
- Brand names listed
- Eagle Electrodes, Eagle Electrodes for TENS & NMES, Eagle Premium Electrodes for Therapist and Clinicians
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 11, 2003 | K030800 | ELECTROMED REUSABLE NEUROSTIMULATION ELECTRODES | GXY | Substantially Equivalent | Eletromed, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Cutaneous
- All makers of Collector, Urine, (And Accessories) For Indwelling Catheter
Updated June 11, 2003. 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.