Medical Device Manufacturer · US , Farmingdale , NY

Misonix, Inc.

17 submissions · 17 cleared · Since 1998
17
Total
17
Cleared
0
Denied

Misonix, Inc. — FDA 510(k) Submissions

Misonix, Inc. has submitted 17 FDA 510(k) premarket notifications since 1998, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Instrument, Ultrasonic Surgical, Wound Cleaner, Ultrasound, System, Ablation, Ultrasound And Accessories, Electrosurgical, Cutting & Coagulation & Accessories, Catheter, Irrigation . Use the specialty filter in the sidebar to narrow results.

17 devices
1–12 of 17
neXus Ultrasonic Surgical Aspirator System
K221235 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Jul 2022 90d
neXus Ultrasonic Surgical Aspirator System
K212060 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Dec 2021 165d
neXus Ultrasonic Surgical Aspirator System
K190160 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
May 2019 120d
SONICONE PLUS ULTRASOUND WOUND CARE SYSTEM AND ACCESSORIES
K123980 · NRB Wound Cleaner, Ultrasound · General & Plastic Surgery
Mar 2013 69d
MISONIX SONICONE(R) ULTRASONIC WOUND CARE SYSTEM AND ACCESSORIES
K112782 · NRB Wound Cleaner, Ultrasound · General & Plastic Surgery
Dec 2011 66d
SONATHERM 600I ULTRASONIC LESION GENERATING SYSTEM
K070779 · NTB System, Ablation,... · General & Plastic Surgery
Jul 2008 476d
MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K070313 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
May 2007 99d
ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF
K062471 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Oct 2006 63d
MISONIX INC. SONATHERM 600 ULTRASONIC LESION GENERATING SYSTEM
K042096 · NTB System, Ablation,... · General & Plastic Surgery
Jan 2006 540d
MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY
K052702 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Nov 2005 54d
AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM
K050776 · LFL Instrument, Ultrasonic... · General & Plastic Surgery
Jun 2005 70d
MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR SYSTEMS
K041058 · QPB System, Suction,... · General & Plastic Surgery
May 2004 24d
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