Mmi North America, Inc.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Mmi North America, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| SAQ | Electromechanical System For Open Microsurgery | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN230032 | De Novo | Electromechanical System For Open Microsurgery | 2024-04-05 |
Recalls
openFDA lists no recalls under a recalling firm named Mmi North America, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Mmi North America, Inc.?
FDA lists 0 510(k) clearances under the applicant name “Mmi North America, Inc.”, plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Mmi North America, Inc.?
The most frequent FDA product codes under this applicant name are SAQ (Electromechanical System For Open Microsurgery, 1).
Next steps
- See all 0 Mmi North America, Inc. clearances with predicates and recalls
- Run predicate analysis for product code SAQ, Mmi North America, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.