Data / Medical devices / United States / Mmi North America, Inc.
Mmi North America, Inc.: FDA-registered device maker in Jacksonville, FL, United States, 2 510(k) clearances
Mmi North America, Inc. is registered with the FDA (registration 3030954512) in Jacksonville, FL, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 5, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030954512
- Address
- Gate Parkway, Building 500, Jacksonville, FL, United States, 32256
- Owner or operator
- MMI North America, Inc. (10090506)
- Roles
- Complaint file establishment
- First device listed
- April 7, 2024
- Registered through
- 2026
- Brand names listed
- Chair Drape, Master Drape, Robot Drape, Symani Surgical System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drape, Surgical, Antimicrobial | KKX | 2 | Complaint file establishment | accessdata.fda.gov |
| Electromechanical System For Open Microsurgery | SAQ | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| April 5, 2024 | DEN230032 | Symani Surgical System | SAQ | Unknown | Mmi North America, Inc. | accessdata.fda.gov |
| September 20, 2010 | K101689 | EMM EQUIPMENT COVER-POLYTHYLENE | KKX | Substantially Equivalent | Exact Medical Manufacturing, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 5, 2024. 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.