Data / Medical devices / United States / Misonix, LLC
Misonix, LLC: FDA-registered device maker in Farmingdale, NY, United States, 10 510(k) clearances
Misonix, LLC is registered with the FDA (registration 2435119) in Farmingdale, NY, United States. It lists 6 device types. The FDA files 10 510(k) clearances under its listings, the newest dated May 30, 2019. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2435119
- Address
- 1938 New Hwy, Farmingdale, NY, United States, 11735
- Owner or operator
- MISONIX, LLC (2435119)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer
- First device listed
- November 27, 2007
- Registered through
- 2026
- Brand names listed
- AUSS-7 Ultrasonic Surgical System, Autosonix, Fibra Sonics Ultrasonic Lithotriptor Model FS-2000, Fibra-Sonics Ultrasonic Surgical Aspirator, LySonix 3000 Ultrasonic Surgical Sy, Misonix® Inc. neXus® Ultrasonic Surgical Aspirator System, Sonastar Ultrasonic Aspirator Syste, SonicOne Plus Ultrasonic Wound Care System and Accessories and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Instrument, Ultrasonic Surgical | LFL | U | Complaint file establishment, Contract manufacturer, Manufacturer, Specification developer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lithotriptor, Ultrasonic | FEO | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Suction, Lipoplasty For Removal | QPB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Wound Cleaner, Ultrasound | NRB | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 30, 2019 | K190160 | neXus Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | Misonix, Inc. | accessdata.fda.gov |
| March 5, 2013 | K123980 | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES | NRB | Substantially Equivalent | Misonix, Inc. | accessdata.fda.gov |
| December 1, 2011 | K112782 | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES | NRB | Substantially Equivalent | Misonix, Inc. | accessdata.fda.gov |
| May 11, 2007 | K070313 | MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | Substantially Equivalent | Misonix, Inc. | accessdata.fda.gov |
| October 26, 2006 | K062471 | ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF | LFL | Substantially Equivalent | Misonix, Inc. | accessdata.fda.gov |
| June 6, 2005 | K050776 | AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | Substantially Equivalent | Misonix, Inc. | accessdata.fda.gov |
| May 17, 2004 | K041058 | MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS | QPB | Substantially Equivalent | Misonix, Inc. | accessdata.fda.gov |
| November 22, 1999 | K993046 | FIBRA SONICS ULTRASONIC LITHOTRIPTOR LITHOSONIC, MODEL LS-2000 | FEO | Substantially Equivalent | Fibra Sonics, Inc. | accessdata.fda.gov |
| September 22, 1998 | K980930 | FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA | LFL | Substantially Equivalent | Fibra Sonics, Inc. | accessdata.fda.gov |
| December 11, 1984 | K842024 | ULTRASONIC LITHOTRIPTOR 300A | FEO | Substantially Equivalent | Fibra Sonics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 13, 2003 | 27501 | Not yet classified | Terminated | LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling: MANUFACTURED BY: MISONIX, INC. EXCLUSIVELY FOR SALE BY MENTOR CORPORATION UNDER EXCLUSIVE LICENSE FROM SONIQUE SURGICAL, INC. MISONIX, INC. 1 | Firm received complaints of tingling or static shock sensation to end users caused by forcing the output connector into its receptacle misaligned. The misalignment causes additional voltage to appear on the patient probe. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Suction, Lipoplasty For Removal
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Instrument, Ultrasonic Surgical
- All makers of Lavage, Jet
- All makers of Wound Cleaner, Ultrasound
- All makers of Lithotriptor, Ultrasonic
Updated May 30, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.