FDA Registration
Active
🇺🇸 United States
MISONIX, LLC
Reg #: 2435119
·
FEI: 2435119
·
Expires 2026
Products
6
Proprietary Names
10
Establishment Types
4
Classifications
6
Registration Details
- Registration Name
- MISONIX, LLC
- Registration Number
- 2435119
- FEI Number
- 2435119
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1938 New Hwy
- City
- Farmingdale
- State
- NY
- ZIP
- 11735
- Country
- US
Regulatory Submissions
- 510(k) Number
- K062471
Owner / Operator
- Firm Name
- MISONIX, LLC
- Operator Number
- 2435119
- Address
- 1938 New Hwy
- City
- Farmingdale
- State
- NY
- Postal Code
- 11735
- Country
- US
- Correspondent
- William Heard
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2007-11-27 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2007-11-27 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2007-11-27 |
| Lavage, Jet | FQH | Class 2 | General Hospital | No | 2018-11-15 |
| Wound Cleaner, Ultrasound | NRB | Class 2 | General, Plastic Surgery | No | 2018-11-15 |
| Lithotriptor, Ultrasonic | FEO | Class 2 | Gastroenterology, Urology | No | 2014-12-22 |
Proprietary Names
Sonastar Ultrasonic Aspirator Syste
LySonix 3000 Ultrasonic Surgical Sy
Fibra-Sonics Ultrasonic Surgical Aspirator
SonicOne Ultrasonic Surgical System
Fibra Sonics Ultrasonic Lithotriptor Model FS-2000
Autosonix
AUSS-7 Ultrasonic Surgical System
Misonix® Inc. neXus® Ultrasonic Surgical Aspirator System
Ultrasonic Lithotriptor 300a
SonicOne Plus Ultrasonic Wound Care System and Accessories
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device for Another Party (Contract Manufacturer)