Bio Med Sciences, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Bio Med Sciences, Inc.” (first 1991, latest 2002), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 69 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | 7 | 7 |
| MGP | Dressing, Wound And Burn, Occlusive | 2 | 2 |
| FRO | Dressing, Wound, Drug | 1 | 1 |
Review panels
Most recent Bio Med Sciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K023136 | OLEEVA FABRIC | MDA | 2002-10-16 | 26 |
| K002109 | OLEEVA FOAM | MDA | 2000-08-31 | 50 |
| K990042 | SILON DUAL-DRESS | FRO | 1999-03-19 | 72 |
| K982036 | SILON SCAR STRIPS | MDA | 1998-08-06 | 57 |
| K952546 | SILON SILICONE TEXTILE COMPOSITE | MDA | 1995-08-07 | 66 |
| K946362 | SILON SILICONE FOAM SHEETING | MDA | 1995-07-13 | 217 |
| K945892 | SILON(R) SILICONE THERMOPLASTIC SHEETING | MDA | 1995-03-03 | 91 |
| K932214 | SILON SILICONE GEL SHEET | MDA | 1994-01-06 | 244 |
| K923150 | SILON TRANSPARENT WOUND DRESSINGS | MGP | 1992-08-27 | 59 |
| K912032 | SILON(TM) TRANSPARENT WOUND DRESSING | MGP | 1991-08-20 | 104 |
Recalls
openFDA lists no recalls under a recalling firm named Bio Med Sciences, 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 Bio Med Sciences, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Bio Med Sciences, Inc.” (first 1991, latest 2002), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bio Med Sciences, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio Med Sciences, Inc. is 69 days.
Which FDA product codes appear under Bio Med Sciences, Inc.?
The most frequent FDA product codes under this applicant name are MDA (Elastomer, Silicone, For Scar Management, 7); MGP (Dressing, Wound And Burn, Occlusive, 2); FRO (Dressing, Wound, Drug, 1).
Next steps
- See all 10 Bio Med Sciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MDA, Bio Med Sciences, 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.