Eximo Medical: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Eximo Medical” (first 2026, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 73 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 | 73 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Eximo Medical took a median 73 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | 1 | 1 |
Review panels
- Cardiovascular (1)
Most recent Eximo Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260244 | Auryon Atherectomy System | MCW | 2026-04-10 | 73 |
Recalls
openFDA lists no recalls under a recalling firm named Eximo Medical.
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.
- Eximo Medical, Ltd. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Eximo Medical?
FDA lists 1 510(k) clearance under the applicant name “Eximo Medical” (first 2026, latest 2026), 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 Eximo Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Eximo Medical is 73 days.
Which FDA product codes appear under Eximo Medical?
The most frequent FDA product codes under this applicant name are MCW (Catheter, Peripheral, Atherectomy, 1).
Next steps
- See all 1 Eximo Medical clearances with predicates and recalls
- Run predicate analysis for product code MCW, Eximo Medical'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.