Fziomed, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Fziomed, Inc.” (first 2026, latest 2026), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 213 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 |
|---|---|---|
| 2026 | 1 | 213 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Fziomed, Inc. took a median 213 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 213 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QVL | Absorbable Gel For Intraoperative Use In Spine Surgery | 2 | 1 |
Review panels
- Orthopedic (2)
Most recent Fziomed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253326 | Oxiplex | QVL | 2026-05-01 | 213 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN240038 | De Novo | Absorbable Gel For Intraoperative Use In Spine Surgery | 2025-06-17 |
Recalls
openFDA lists no recalls under a recalling firm named Fziomed, 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.
Device clinical trials
An industry sponsor named Fziomed, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06593977: Evaluation of Dynavisc in Pain Reduction Following Revision Surgery for Persistent or Recurrent Carpal Tunnel Syndrome (Recruiting, started 2026-03-26)
- NCT03433391: Confirmatory Clinical Study of Oxiplex (Completed, started 2018-04-23)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fziomed, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Fziomed, Inc.” (first 2026, latest 2026), plus 1 De Novo decision, 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 Fziomed, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fziomed, Inc. is 213 days.
Which FDA product codes appear under Fziomed, Inc.?
The most frequent FDA product codes under this applicant name are QVL (Absorbable Gel For Intraoperative Use In Spine Surgery, 2).
Next steps
- See all 1 Fziomed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QVL, Fziomed, 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.