Contract manufacturerANODYNE SURGICAL (O Fallon, MO)MissouriCardiovascularGeneral and plastic surgeryOphthalmicClass IIClass I
ANODYNE SURGICAL
Contract manufacturer ยท O Fallon, MO
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 1929756 (openFDA record; or search FDA's registration database)
- FEI number
- 1929756
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- PSI/EYE-KO, INC. (FDA owner/operator no. 1929756)
- Registered address
- 804 Corporate Centre Dr, O Fallon, MO 63368
- Contract listings
- 14 device listings, 14 product codes, first listed Jan 4, 1993
- 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 |
|---|---|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Class II | Cardiovascular | Contract manufacturing | Feb 6, 2013 |
| GAA | Needle, Aspiration And Injection, Disposable | Class I | General and plastic surgery | Contract manufacturing | Jan 4, 1993 |
| GAE | Snare, Surgical | Class I | General and plastic surgery | Contract manufacturing | Nov 12, 2010 |
| GDM | Needle, Aspiration And Injection, Reusable | Class I | General and plastic surgery | Contract manufacturing | Jan 4, 1993 |
| HMX | Cannula, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Oct 7, 1994 |
| HND | Spatula, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Jan 4, 1993 |
| HNI | Retractor, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Jan 4, 1993 |
| HNL | Probe, Lachrymal | Class I | Ophthalmic | Contract manufacturing | Jan 4, 1993 |
| HNN | Knife, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Jan 4, 1993 |
| HNQ | Hook, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Jan 4, 1993 |
| HNY | Cystotome | Class I | Ophthalmic | Contract manufacturing | Nov 12, 2010 |
| KYG | Device, Irrigation, Ocular Surgery | Class I | Ophthalmic | Contract manufacturing | Nov 12, 2010 |
| MXY | Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | Class I | Ophthalmic | Contract manufacturing | Nov 12, 2010 |
| NGY | Cannula, Trocar, Ophthalmic | Class I | Ophthalmic | Contract manufacturing | Nov 12, 2010 |