Velopex International, Inc.
Saint Cloud, FL, US
VELOPEX INTERNATIONAL, INC. appears in FDA device records in Saint Cloud, FL. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Velopex International, Inc. between 2003 and 2011. The busiest year on record is 2003, with 1. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K111167 | XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT | IXW | Substantially Equivalent | |
| K093503 | INTRAX FILM PROCESSOR | IXW | Substantially Equivalent | |
| K024105 | VELOPEX AQUACUT FLUID ABRASION UNIT | KOJ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003697084 | 3003697084 | VELOPEX INTERNATIONAL, INC. | 105 EAST 17TH ST., Saint Cloud, FL 34769 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain