Company ยท US
Misonix, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2026. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 2026 | K261448 | neXus Ultrasonic Surgical Aspirator System Misonix, LLC | LFL |
| Jul 28, 2022 | K221235 | neXus Ultrasonic Surgical Aspirator System Misonix, Inc. | LFL |
| Dec 13, 2021 | K212060 | neXus Ultrasonic Surgical Aspirator System Misonix, Inc. | LFL |
| May 30, 2019 | K190160 | neXus Ultrasonic Surgical Aspirator System Misonix, Inc. | LFL |
| Mar 5, 2013 | K123980 | SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES Misonix, Inc. | NRB |
| Dec 1, 2011 | K112782 | MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES Misonix, Inc. | NRB |
| Jul 9, 2008 | K070779 | SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM Misonix, Inc. | NTB |
| May 11, 2007 | K070313 | MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM Misonix, Inc. | LFL |
| Oct 26, 2006 | K062471 | ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF Misonix, Inc. | LFL |
| Jan 26, 2006 | K042096 | MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM Misonix, Inc. | NTB |
| Nov 21, 2005 | K052702 | MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY Misonix, Inc. | GEI |
| Jun 6, 2005 | K050776 | AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM Misonix, Inc. | LFL |
| May 17, 2004 | K041058 | MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS Misonix, Inc. | QPB |
| Dec 9, 2003 | K032690 | MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM Misonix, Inc. | LFL |
| Jan 10, 2002 | K013417 | MISONIX IRRIGATION SYSTEM MOEDL BC20P Misonix, Inc. | GBX |
| Jul 27, 2001 | K012028 | ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 Misonix, Inc. | LFL |
| Oct 10, 2000 | K000927 | ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-4 Misonix, Inc. | LFL |
| Sep 4, 1998 | K982841 | MODIFICATION TO ALLIGER ULTRASONIC SURGICAL SYSTEM, MODEL AUSS-4 Misonix, Inc. | LFL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2003 | Misonix, Inc 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 SURGICA Terminated |
LFL | K933559 |