Proxy Biomedical , Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Proxy Biomedical , Ltd.” (first 2005, latest 2018), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 30 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 | 1 | 241 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Proxy Biomedical , Ltd. took a median 241 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTL | Mesh, Surgical, Polymeric | 5 | 5 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | 1 | 1 |
Review panels
Most recent Proxy Biomedical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172636 | VitaMESH Macroporous PP Surgical Mesh | FTL | 2018-04-30 | 241 |
| K111121 | VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH | FTL | 2011-05-13 | 22 |
| K060520 | VITAMESH MACROPOROUS PP SURGICAL MESH | FTL | 2006-03-28 | 29 |
| K052100 | MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH | FTL | 2005-08-11 | 8 |
| K051245 | POLYFORM SYNTHETIC MESH | OTO | 2005-06-17 | 32 |
| K050678 | MOTIFMESH SOFT TISSUE PATCH | FTL | 2005-05-20 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Proxy Biomedical , Ltd..
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 Proxy Biomedical , Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Proxy Biomedical , Ltd.” (first 2005, latest 2018), 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 Proxy Biomedical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Proxy Biomedical , Ltd. is 30 days.
Which FDA product codes appear under Proxy Biomedical , Ltd.?
The most frequent FDA product codes under this applicant name are FTL (Mesh, Surgical, Polymeric, 5); OTO (Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed, 1).
Next steps
- See all 6 Proxy Biomedical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FTL, Proxy Biomedical , Ltd.'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.