Data / Medical devices / United States / MLM Biologics
MLM Biologics: FDA-registered device maker in Alachua, FL, United States, 1 510(k) clearance
MLM Biologics is registered with the FDA (registration 3042708438) in Alachua, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 22, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042708438
- FEI number
- 3009710316
- Address
- 13700 Progress Blvd, Alachua, FL, United States, 32615
- Owner or operator
- MLM Biologics (10047385)
- Roles
- Manufacturer
- First device listed
- August 20, 2014
- Registered through
- 2026
- Brand names listed
- OrthoNovis Connect, bio-ConneKt Wound Matrix
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Wound Dressing With Animal-Derived Material(S) | KGN | U | 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 |
|---|---|---|---|---|---|---|
| July 22, 2014 | K140456 | BIO-CONNEKT WOUND MATRIX | KGN | Substantially Equivalent | MLM Biologics, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 22, 2014. 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.