FDA Registration
Active
🇺🇸 United States
ANODYNE SURGICAL
Reg #: 1929756
·
FEI: 1929756
·
Expires 2026
Products
25
Proprietary Names
51
Establishment Types
3
Classifications
25
Registration Details
- Registration Name
- ANODYNE SURGICAL
- Registration Number
- 1929756
- FEI Number
- 1929756
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 804 Corporate Centre Dr
- City
- O Fallon
- State
- MO
- ZIP
- 63368
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160710
Owner / Operator
- Firm Name
- PSI/EYE-KO, INC.
- Operator Number
- 1929756
- Address
- 804 CORPORATE CENTRE DR., --
- City
- O Fallon
- State
- MO
- Postal Code
- 63368
- Country
- US
- Correspondent
- Valerie Anderson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2023-07-18 |
| Cystotome | HNY | Class 1 | Ophthalmic | No | 2010-11-12 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 1993-01-04 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 2023-07-18 |
| Lacrimal Stents And Intubation Sets | OKS | Class U | Unknown | No | 2019-05-02 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 1993-01-04 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 1993-01-04 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 1993-01-04 |
| Sponge, Ophthalmic | HOZ | Class 2 | Ophthalmic | No | 2022-05-04 |
| Needle, Aspiration And Injection, Reusable | GDM | Class 1 | General, Plastic Surgery | No | 1993-01-04 |
| Surgical Eye Tray | PZG | Class 1 | Ophthalmic | No | 2023-12-27 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 1993-01-04 |
| Marker, Ocular | HMR | Class 1 | Ophthalmic | No | 2023-07-18 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2023-07-20 |
| Caliper, Ophthalmic | HOE | Class 1 | Ophthalmic | No | 2023-07-18 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2013-02-06 |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | Class 1 | Ophthalmic | No | 2010-11-12 |
| Probe, Lachrymal | HNL | Class 1 | Ophthalmic | No | 1993-01-04 |
| Device, Irrigation, Ocular Surgery | KYG | Class 1 | Ophthalmic | No | 2010-11-12 |
| Snare, Surgical | GAE | Class 1 | General, Plastic Surgery | No | 2010-11-12 |
| Dilator, Lachrymal | HNW | Class 1 | Ophthalmic | No | 2023-07-18 |
| Retractor, Ophthalmic | HNI | Class 1 | Ophthalmic | No | 1993-01-04 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2010-11-12 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2023-07-18 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 1994-10-07 |
Proprietary Names
Anodyne Surgical Tray, Surgical
Capsulorhexis
Irrigating
STILETTO AND SINGLE EDGE KNIFES
Anodyne Surgical Scissors, Ophthalmic
SIMCOLE LENS LOOP
RAIN IRIS
MICRO LENS
Non Atkinson
Atkinson
Retrobulbar Needles
Peribulbar Needles
Anodyne Surgical PVA Spears
Peribulbar
Retrobulbar
Surgical Eye Tray, Forsight Kit
KRATZ
BARRAQUER
wire
solid blade
Child
pediatric
Anodyne Surgical Marker, ocular
Anodyne Surgical Forceps, ophthalmic
Anodyne Surgical Caliper, ophthalmic
IMA Cannula
SQUEEGEE
BOWMAN
PIGTAIL PROBE W/SUTURE
CRAWFORD/CATLANO INTUBATION
PROBE, LACHRYMAL
Sinskey
Kellan
P. Koch
Chang
Hydrodissector
Multiple Snares
Anodyne Surgical Dilator, lachrymal
FENZL
JAFFE
IRIS
HUTCHISON
Trocar
Anodyne Surgical Handle, Scalpel
CHARLEUX
CHANG
SIMCOE
PEYMAN
HESSBURG
LAMBERT
BINKHORST
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device