FDA Registration
Active
🇺🇸 United States
SYNERGETICS, INC.
Reg #: 1932402
·
FEI: 1000119053
·
Expires 2026
Products
17
Proprietary Names
0
Establishment Types
4
Classifications
17
Registration Details
- Registration Name
- SYNERGETICS, INC.
- Registration Number
- 1932402
- FEI Number
- 1000119053
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3845 Corporate Centre Dr
- City
- O Fallon
- State
- MO
- ZIP
- 63368
- Country
- US
Regulatory Submissions
- 510(k) Number
- K952585
Owner / Operator
- Firm Name
- SYNERGETICS, INC.
- Operator Number
- 9005675
- Address
- 400 Somerset Corporate Blvd., --
- City
- Bridgewater
- State
- NJ
- Postal Code
- 08807
- Country
- US
- Correspondent
- Margaret - Wood
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoilluminator | MPA | Class 2 | Gastroenterology, Urology | No | 2015-05-22 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2017-01-17 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2008-03-12 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 2013-04-25 |
| Photocoagulator And Accessories | HQB | Class 2 | Ophthalmic | No | 2013-02-14 |
| Instrument, Microsurgical | GZX | Class 1 | Neurology | No | 1996-10-28 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 1999-02-03 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 1992-09-14 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2011-11-21 |
| Magnet, Permanent | HPN | Class 1 | Ophthalmic | No | 1996-10-28 |
| Pump, Infusion, Ophthalmic | MRH | Class 2 | General Hospital | No | 2021-05-24 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 2014-11-26 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2025-06-16 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 1992-06-12 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 1996-10-28 |
| Apparatus, Cautery, Radiofrequency, Ac-Powered | HQR | Class 2 | Ophthalmic | No | 2012-12-06 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 1992-09-14 |
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198