Woodside Biomedical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Woodside Biomedical, Inc.” (first 1998, latest 2002), across 1 product code in 1 review panel. Median 510(k) review time under this name: 82 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 |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 6 | 6 |
Review panels
- Neurology (6)
Most recent Woodside Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K020180 | RELIEFBAND DEVICE, MODELS RB-DL, RB-EL, RB-RL | GZJ | 2002-03-21 | 62 |
| K994387 | RELIEFBAND NST DEVICE, MODEL WB-2L, WB-6L, WB-RL | GZJ | 2000-03-16 | 79 |
| K983907 | RELIEFBAND NST DEVICE MODELS WB-2,WB-6,WB-R | GZJ | 1999-12-09 | 401 |
| K982967 | RELIEFBAND MST DEVICE, MODELS RB-2, RB-6, RB-R | GZJ | 1999-02-23 | 182 |
| K982436 | RELIEFBAND NST DEVICE, MODEL #'S WB-2, WB-6 AND WB-R | GZJ | 1998-10-08 | 86 |
| K980333 | RELIEFBAND | GZJ | 1998-02-18 | 21 |
Recalls
openFDA lists no recalls under a recalling firm named Woodside Biomedical, 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 Woodside Biomedical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Woodside Biomedical, Inc.” (first 1998, latest 2002), across 1 product code 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 Woodside Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Woodside Biomedical, Inc. is 82 days.
Which FDA product codes appear under Woodside Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 6).
Next steps
- See all 6 Woodside Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Woodside Biomedical, 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.