Dilon Medical Technologies, Ltd.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Dilon Medical Technologies, 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 |
|---|---|---|---|
| OEE | Diagnostic Low Electric Field | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P110014 | PMA | DUNE MEDICAL DEVICES MARGINPROBE SYSTEM | 2012-12-27 |
Recalls
openFDA lists no recalls under a recalling firm named Dilon Medical Technologies, 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 Dilon Medical Technologies, Ltd. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05377229: MarginProbe 2.0 Data Collection Protocol (Completed, started 2021-12-15)
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.
- Dilon Technologies, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Dilon Medical Technologies, Ltd.?
FDA lists 0 510(k) clearances under the applicant name “Dilon Medical Technologies, 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 Dilon Medical Technologies, Ltd.?
The most frequent FDA product codes under this applicant name are OEE (Diagnostic Low Electric Field, 1).
Next steps
- See all 0 Dilon Medical Technologies, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code OEE, Dilon Medical Technologies, 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.