Data / Medical devices / United States / Edm Imaging Usa LLC
Edm Imaging Usa LLC: FDA-registered device maker in Davie, FL, United States, 1 510(k) clearance
Edm Imaging Usa LLC is registered with the FDA (registration 3013369910) in Davie, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 8, 2008. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013369910
- Address
- 4081 Sw 47th Ave Ste 10, Davie, FL, United States, 33314
- Owner or operator
- EDM Imaging USA LLC (10056408)
- Roles
- Specification developer
- First device listed
- December 18, 2025
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | EZL | 2 | Specification developer | 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 8, 2008 | K082815 | WELL LEAD SILICONE AND LATEX FOLEY CATHETERS | EZL | Substantially Equivalent | Well Lead Medical Instruments | accessdata.fda.gov |
Compare with other makers
Updated October 8, 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.