Fidia Pharmaceutical Corp.: FDA clearances and approvals
Fidia Pharmaceutical Corp. has 10 FDA 510(k) clearances (first 1997, latest 1999), across 1 product code in 1 review panel. Median 510(k) review time: 140 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 |
|---|---|---|---|
| MGQ | Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | 10 | 10 |
Review panels
Most recent Fidia Pharmaceutical Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984413 | BIONECT HYDROGEL | MGQ | 1999-02-10 | 85 |
| K984267 | MODIFICATION OF BIONECT HYDROGEL FOAM | MGQ | 1999-02-10 | 85 |
| K984266 | MODIFICATION OF BIONECT HYDROGEL SPRAY | MGQ | 1999-02-10 | 85 |
| K984264 | MODIFICATION OF BIONECT CLEAR HYDROGEL | MGQ | 1999-02-10 | 85 |
| K984262 | MODIFICATION OF BIONECT HYDROGEL GAUZE PADS | MGQ | 1999-02-10 | 85 |
| K973725 | BIONECT CLEAR HYDROGEL | MGQ | 1998-09-22 | 357 |
| K973724 | BIONECT HYDROGEL SPRAY | MGQ | 1998-09-22 | 357 |
| K973722 | BIONECT HYDROGEL FOAM | MGQ | 1998-09-22 | 357 |
| K973721 | BIONECT HYDROGEL GAUZE PADS | MGQ | 1998-09-22 | 357 |
| K963004 | BIONECT CREAM | MGQ | 1997-02-12 | 194 |
Recalls
openFDA lists no recalls under a recalling firm named Fidia Pharmaceutical Corp..
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 Fidia Pharmaceutical Corp. have?
Fidia Pharmaceutical Corp. has 10 FDA 510(k) clearances (first 1997, latest 1999), across 1 product code in 1 review panel.
How long does FDA take to clear Fidia Pharmaceutical Corp.'s 510(k)s?
The median time from FDA receipt to decision across Fidia Pharmaceutical Corp.'s cleared 510(k)s is 140 days.
What devices does Fidia Pharmaceutical Corp. make?
Its most frequent FDA product codes are MGQ (Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, 10).
Has Fidia Pharmaceutical Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Fidia Pharmaceutical Corp. Related entities may recall under other names.
Next steps
- See all 10 Fidia Pharmaceutical Corp. clearances with predicates and recalls
- Run predicate analysis for product code MGQ, Fidia Pharmaceutical Corp.'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.