Misonix, LLC
Farmingdale, NY, US
MISONIX, LLC appears in FDA device records in Farmingdale, NY. FDA records list 18 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Misonix, LLC between 1998 and 2026. The busiest year on record is 2005, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261448 | neXus Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | |
| K221235 | neXus Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | |
| K212060 | neXus Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | |
| K190160 | neXus Ultrasonic Surgical Aspirator System | LFL | Substantially Equivalent | |
| K123980 | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES | NRB | Substantially Equivalent | |
| K112782 | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES | NRB | Substantially Equivalent | |
| K070779 | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM | NTB | Substantially Equivalent | |
| K070313 | MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | Substantially Equivalent | |
| K062471 | ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF | LFL | Substantially Equivalent | |
| K042096 | MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM | NTB | Substantially Equivalent | |
| K052702 | MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY | GEI | Substantially Equivalent | |
| K050776 | AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | Substantially Equivalent | |
| K041058 | MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS | QPB | Substantially Equivalent | |
| K032690 | MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM | LFL | Substantially Equivalent | |
| K013417 | MISONIX IRRIGATION SYSTEM MOEDL BC20P | GBX | Substantially Equivalent | |
| K012028 | ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 | LFL | Substantially Equivalent | |
| K000927 | ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4 | LFL | Substantially Equivalent | |
| K982841 | MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4 | LFL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2435119 | 2435119 | MISONIX, LLC | 1938 New Hwy, Farmingdale, NY 11735 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0070-04 | 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. 1938 NEW HIGHWAY, FARMINGDALE, NY 11735. Device was manufactured from September 1996 to present. | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain