Veryan Medical, Ltd.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Veryan Medical, Ltd.”, plus 1 PMA decision, across 1 product code in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NIP | Stent, Superficial Femoral Artery | 1 | 0 |
Review panels
- Cardiovascular (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P180003 | PMA | BioMimics 3D Vascular Stent System | 2018-10-04 |
Recalls
openFDA lists no recalls under a recalling firm named Veryan Medical, 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.
Device clinical trials
An industry sponsor named Veryan Medical, Ltd. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02900924: Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D (Completed, started 2016-09)
- NCT02400905: Evaluation of Safety and Effectiveness of the BioMimics 3D Stent System (Completed, started 2015-06-29)
- NCT02163863: BioMimics 3D Stent Clinical Investigation: The Mimics Study (Completed, started 2010-02)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Veryan Medical Limited (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Veryan Medical, Ltd.?
FDA lists 0 510(k) clearances under the applicant name “Veryan Medical, Ltd.”, plus 1 PMA decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Veryan Medical, Ltd.?
The most frequent FDA product codes under this applicant name are NIP (Stent, Superficial Femoral Artery, 1).
Next steps
- See all 0 Veryan Medical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NIP, Veryan Medical, 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.