Contract manufacturerONDAL MEDICAL SYSTEMS OF AMERICA, INC. (Sandston, VA)VirginiaGeneral hospitalGeneral and plastic surgeryRadiologyClass IClass II
ONDAL MEDICAL SYSTEMS OF AMERICA, INC.
Contract manufacturer · Sandston, VA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009028104 (openFDA record; or search FDA's registration database)
- FEI number
- 3009028104
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Contract manufacturer
- Owner or operator
- Ondal Medical Systems of America, Inc. (FDA owner/operator no. 10042526)
- Registered address
- 540 Eastpark Ct Ste A, Sandston, VA 23150
- Contract listings
- 4 device listings, 4 product codes, first listed Feb 10, 2015
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| FOX | Stand, Infusion | Class I | General hospital | Contract manufacturing | Feb 10, 2015 |
| FQO | Table, Operating-Room, Ac-Powered | Class I | General and plastic surgery | Contract manufacturing | Apr 1, 2015 |
| FSY | Light, Surgical, Ceiling Mounted | Class II | General and plastic surgery | Contract manufacturing | Jun 8, 2018 |
| LMD | System, Digital Image Communications, Radiological | Class I | Radiology | Contract manufacturing | Nov 1, 2024 |