Data / Medical devices / United States / Med-Dyne
Med-Dyne: FDA-registered device maker in Louisville, KY, United States, 2 510(k) clearances
Med-Dyne is registered with the FDA (registration 1531159) in Louisville, KY, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 20, 2008. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1531159
- FEI number
- 3002947950
- Address
- 2775 South Floyd ST., Louisville, KY, United States, 40209
- Owner or operator
- MED-DYNE (9040049)
- Roles
- Manufacturer
- First device listed
- March 25, 2004
- Registered through
- 2027
- Brand names listed
- Cable, Electrode, Med-Dyne
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Manufacturer | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 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 |
|---|---|---|---|---|---|---|
| June 20, 2008 | K080112 | PATIENT CABLE | DSA | Substantially Equivalent | Med-Dyne | accessdata.fda.gov |
| May 25, 2005 | K050248 | ELECTRODE | DRX | Substantially Equivalent | Electramold | accessdata.fda.gov |
Compare with other makers
- All makers of Electrode, Electrocardiograph
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Cable, Electrode
Updated June 20, 2008. 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.