Data / Medical devices / United States / Medical Innovations International
Medical Innovations International: FDA-registered device maker in Rochester, MN, United States, 2 510(k) clearances
Medical Innovations International is registered with the FDA (registration 2183762) in Rochester, MN, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 28, 2001. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2183762
- Address
- 6256 34TH Ave., N.W., Rochester, MN, United States, 55901
- Owner or operator
- Medical Innovations International (10094185)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 18, 2025
- Registered through
- 2026
- Brand names listed
- Barton Button, Barton Tracheostoma Button, Bone Biopsy Trephine Set, Rochester Bone Biopsy Trephine, Rochester Nasal Septal Button, Silmed Nasal Septal Button
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Button, Nasal Septal | LFB | U | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Trephine | HWK | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Tube, Laryngectomy | KAC | 1 | Complaint file establishment, Manufacturer, 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 |
|---|---|---|---|---|---|---|
| November 28, 2001 | K013696 | SILMED NASAL SEPTAL BUTTON | LFB | Substantially Equivalent | Silmed, Inc. | accessdata.fda.gov |
| June 14, 1990 | K901377 | BARTON-MAYO TRACHEOSTOMA BUTTON | KAC | Substantially Equivalent | Medical Innovations International, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 28, 2001. 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.