MISONIX, LLC

FDA Device Registration & Listing · Farmingdale, NY, US · Registration 2435119

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2435119
FEI Number
2435119
Entity Name
MISONIX, LLC
City/State/Country
Farmingdale, NY, US
Establishment Address
1938 New Hwy, Farmingdale, NY 11735, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
MISONIX, LLC (Owner Number: 2435119)
Owner / Operator Contact Address
1938 New Hwy, Farmingdale, NY 11735, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K842024
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2007-11-27
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2007-11-27
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2007-11-27
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2014-12-29
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2007-11-27
FQH Lavage, Jet General Hospital Class 2 880.5475 2018-11-15
NRB Wound Cleaner, Ultrasound General, Plastic Surgery Class 2 878.4410 2018-11-15
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2014-12-22
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2012-11-06
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2007-11-27
LFL Instrument, Ultrasonic Surgical Unknown Class U N/A 2019-10-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2019-10-16
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2014-12-29

Official Correspondent

William Heard

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MISONIX, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0332-2022 Covidien Llc U
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2435119. Last updated year: 2026. Please use registration number 2435119 when referencing this establishment in official correspondence.
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