Bridger Biomed, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Bridger Biomed, Inc.” (first 1997, latest 2001), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 4 | 4 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | 2 |
| GXQ | Dura Substitute | 1 | 1 |
Review panels
Most recent Bridger Biomed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003917 | MODIFICATION TO FLUOROTEX II SURGICAL MESH | FTL | 2001-01-26 | 38 |
| K003906 | MODIFICATION TO FLUROTEX SURGICAL MESH | FTL | 2001-01-26 | 38 |
| K002351 | FLUOROTEX II SURGICAL MESH | FTL | 2000-08-26 | 24 |
| K994032 | FLUORO-TEX CARDIOVASCULAR PATCH | DXZ | 2000-07-07 | 224 |
| K984197 | FLUOROTEX SURGICAL MESH | FTL | 1999-01-07 | 45 |
| K980548 | DURA-PATCH MODEL DP-XXX | GXQ | 1998-05-13 | 90 |
| K973178 | FLUORO-TEX SURGICAL MEMBRANE | DXZ | 1997-11-24 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Bridger Biomed, 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 Bridger Biomed, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Bridger Biomed, Inc.” (first 1997, latest 2001), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Bridger Biomed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bridger Biomed, Inc. is 45 days.
Which FDA product codes appear under Bridger Biomed, Inc.?
The most frequent FDA product codes under this applicant name are FTL (Mesh, Surgical, Polymeric, 4); DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 2); GXQ (Dura Substitute, 1).
Next steps
- See all 7 Bridger Biomed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTL, Bridger Biomed, 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.