Millennium Biomedical, Inc.: FDA clearances and approvals
Millennium Biomedical, Inc. has 5 FDA 510(k) clearances (first 2000, latest 2004), across 1 product code in 1 review panel. Median 510(k) review time: 89 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HNO | Keratome, Ac-Powered | 5 | 5 |
Review panels
- Ophthalmic (5)
Most recent Millennium Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041110 | MB 105 MILLENNIUM BLADES | HNO | 2004-10-13 | 168 |
| K020122 | MB 102 MILLENNIUM BLADES | HNO | 2002-02-15 | 32 |
| K011833 | MB 103 MILLENNIUM BLADES | HNO | 2002-02-15 | 248 |
| K003143 | MILLENNIUM BLADES, MODEL MB101 | HNO | 2000-12-11 | 62 |
| K001806 | REFRACTIVE SURGERY BLADES | HNO | 2000-09-12 | 89 |
Recalls
openFDA lists no recalls under a recalling firm named Millennium Biomedical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Millennium Biomedical, Inc. have?
Millennium Biomedical, Inc. has 5 FDA 510(k) clearances (first 2000, latest 2004), across 1 product code in 1 review panel.
How long does FDA take to clear Millennium Biomedical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Millennium Biomedical, Inc.'s cleared 510(k)s is 89 days.
What devices does Millennium Biomedical, Inc. make?
Its most frequent FDA product codes are HNO (Keratome, Ac-Powered, 5).
Has Millennium Biomedical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Millennium Biomedical, Inc. Related entities may recall under other names.
Next steps
- See all 5 Millennium Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HNO, Millennium Biomedical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.