Biomerix Corporation: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Biomerix Corporation” (first 2005, latest 2011), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 114 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 | 5 | 5 |
| KRD | Device, Vascular, For Promoting Embolization | 1 | 1 |
Review panels
Most recent Biomerix Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112567 | BIOMERIX ASSURE | FTL | 2011-12-23 | 112 |
| K112499 | BIOMERIX COMPOSITE SURGICAL MESH | FTL | 2011-12-23 | 115 |
| K093123 | BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB | FTL | 2010-05-13 | 223 |
| K082941 | BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215 | FTL | 2009-01-07 | 97 |
| K070961 | BIOMERIX SURGICAL MESH, MODEL: RCR-01 | FTL | 2008-02-25 | 326 |
| K043371 | BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER | KRD | 2005-02-03 | 57 |
Recalls
openFDA lists no recalls under a recalling firm named Biomerix Corporation.
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 Biomerix Corporation?
FDA lists 6 510(k) clearances under the applicant name “Biomerix Corporation” (first 2005, latest 2011), across 2 product codes in 2 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 Biomerix Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomerix Corporation is 114 days.
Which FDA product codes appear under Biomerix Corporation?
The most frequent FDA product codes under this applicant name are FTL (Mesh, Surgical, Polymeric, 5); KRD (Device, Vascular, For Promoting Embolization, 1).
Next steps
- See all 6 Biomerix Corporation clearances with predicates and recalls
- Run predicate analysis for product code FTL, Biomerix Corporation'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.