Edap International Corp.: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Edap International Corp.”, plus 2 PMA decisions, 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 |
|---|---|---|---|
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 2 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P880042 | PMA | EDAP LT.01 SHOCK WAVE LITHOTRIPTER | 1991-12-12 |
| P880011 | PMA | TECHNOMED INTERNATIONAL SONOLITH 2000 | 1989-06-23 |
Recalls
openFDA lists no recalls under a recalling firm named Edap International Corp..
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.
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.
- Edap Technomed, Inc. (5 510(k)s)
- Edap Tms France (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Edap International Corp.?
FDA lists 0 510(k) clearances under the applicant name “Edap International Corp.”, plus 2 PMA decisions, 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 Edap International Corp.?
The most frequent FDA product codes under this applicant name are LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological, 2).
Next steps
- See all 0 Edap International Corp. clearances with predicates and recalls
- Run predicate analysis for product code LNS, Edap International Corp.'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.