Atlas FDA

LFL

158 FDA 510(k) clearances · Product code

90 daysmedian time to decision
251 days90th percentile
158clearances measured

FDA profile

Official device name
Instrument, Ultrasonic Surgical
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
2021: 3,289 · 2022: 3,422 · 2023: 4,215 · 2024: 4,017 · 2025: 3,907 · 2026: 2,349
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
neXus Ultrasonic Surgical Aspirator System (K261448)Misonix, LLC2026-07-30
CUSA® Clarity Ultrasonic Surgical Aspirator System (K251162)Integra LifeSciences Corporation2025-10-08
SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45) (K242894)Shanghai Saints Sages Surgical Co., Ltd.2025-06-18
Sonopet iQ Ultrasonic Aspirator System (5500-050-000) (K243930)Stryker Instruments2025-03-24
Tenex 2nd Generation System (K241700)Trice Medical, Inc.2024-11-18
CUSA® Clarity Ultrasonic Surgical Aspirator System (K240493)Integra LifeSciences Corporation2024-07-11
Ultrasonic Surgical System (K233036)Hunan Handlike Minimally Invasive Surgery Co., Ltd.2024-06-18
CUSA Clarity Ultrasonic Surgical Aspirator System (K230427)Integra LifeSciences Corporation2023-07-11
neXus Ultrasonic Surgical Aspirator System (K231117)Misonix, LLC, A Bioventus Company2023-06-23
HARMONIC 700 Shears (K221790)Ethicon Endo-Surgery, LLC2023-02-28
Sonopet 1Q 3 7cm 1Q Large (K223770)Stryker Corporation2023-02-16
LOTUS Series 4 Enhanced Shears, LOTUS Series 5 (K221102)Sra Developments, Ltd.2022-12-15
Ultrasonic Surgical System (K210567)Miconvey Technologies Co., Ltd.2022-09-30
CUSA Clarity Ultrasonic Surgical Aspirator System (K221835)Integra LifeSciences Corporation2022-08-22
neXus Ultrasonic Surgical Aspirator System (K221235)Misonix, Inc.2022-07-28
Ultrasonic Scalpel System (K212614)Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.2022-07-18
CUSA Clarity Ultrasonic Surgical Aspirator System (K221763)Integra LifeSciences Corporation2022-07-15
Oclet TDS 1000 (K212049)Tendonova Corporation2022-03-08
Sonopet iQ Ultrasonic Aspirator System (K213824)Stryker Corporation2022-02-03
neXus Ultrasonic Surgical Aspirator System (K212060)Misonix, Inc.2021-12-13
Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device (K212301)Covidien, LLC2021-11-15
Ultrasonic Surgical Aspirator System, Model: XD880B (K212750)Smtp Technology Co., Ltd.2021-09-27
Ultrasonic Bipolar Generator USG-410 with accessories (K211838)Olympus Medical Systems Corporation2021-08-04
Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray (K211273)Ethicon Endo-Surgery, LLC2021-05-21
Ultrasonic Surgical Aspirator System (K202299)Smtp Technology Co., Ltd.2021-05-21
Sonicision Cordless Ultrasonic Dissector (K200427)Covidien, LLC2020-07-10
CUSA Clarity Ultrasonic Surgical Aspirator System (K200774)Integra LifeSciences Corporation2020-06-23
Kogent Torus Ultrasonic Aspirator (K192963)Katalyst Surgical, LLC2020-06-19
HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length (K191555)Ethicon Endo-Surgery, LLC2020-02-28
Ultrasonic Surgical System (K190281)Medisonic Technology CO2019-10-31
neXus Ultrasonic Surgical Aspirator System (K190160)Misonix, Inc.2019-05-30
Sonopet iQ Ultrasonic Aspirator System (K190070)Stryker Corporation2019-04-11
CUSA Clarity Ultrasonic Surgical Aspirator System (K190180)Integra LifeSciences Corporation2019-04-01
CUSA Clarity Ultrasonic Surgical Aspirator System (K182809)Integra LifeSciences Corporation2018-12-07
Tenex Health TX System with the TXP MicroTip (K181367)Tenex Health, Inc.2018-08-28
Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide (K180149)Covidien, LLC2018-03-26
Ultrasonic Generator (K172691)Olympus Medical Systems Corp.2017-10-04
CUSA Excel+ Ultrasonic Surgical Aspirator System (K172595)Integra LifeSciences Corporation2017-09-28
CUSA Clarity Ultrasonic Surgical Aspirator System (K161882)Integra LifeSciences Corporation2016-10-14
HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length (K160752)Ethicon Endo-Suregery, LLC2016-06-29
Sonicision Cordless Ultrasonic Dissection Device (K153371)Covidien, LLC2016-03-28
HARMONIC HOOK (K151136)Ethicon Endo-Surgery, LLC2016-03-04
Tenex Health TX System (K153299)Tenex Health, Inc.2016-03-03
CUSA Excel+ (K150682)Integra Lifesciences Corp.2015-12-18
Lotus Series 4 Ultrasonic Surgical System & Accessories (K151101)Sra Developments, Ltd.2015-07-17
HARMONIC Focus Long Shears + Adaptive Tissue Technology (K151340)Ethicon Endo-Surgery, LLC2015-07-10
Prime Adaptive Ultrasonic Scalpel System (K150271)Endoprime, Inc.2015-05-29
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K141668)Integra LifeSciences Corporation2014-11-06
CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K141674)Integra LifeSciences Corporation2014-11-06
SONICISION CORDLESS ULTRASONIC DISSECTOR (K141371)Covidien, Formerly Valleylab, A Division of Tyco H2014-08-07
HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE (K132522)Ethicon Endo-Surgery, LLC2013-12-16
HARMONIC FOCUS SHEARS + ADAPTIVE TISSUE TECHNOLOGY (K133314)Ethicon Endo-Surgery, LLC2013-12-03
HARMONIC ACE CURVED SHEARS WITH SCISSOR HANDLE, HARMONIC ACE CURVED SHEARS WITH ERGONOMIC HANDLE (K132512)Ethicon Endo-Surgery, LLC2013-10-24
HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE (K132612)Ethicon Endo-Surgery, LLC2013-10-17
TX1 TISSUE REMOVAL SYSTEM (K123640)Tenex Health2013-03-20
HARMONIC ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH + ADAPTIVE TISSUE TECHNOLOGY (K121550)Ethicon Endo-Surgery, LLC2012-08-22
HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 (K120729)Ethicon Endo-Surgery, LLC2012-05-17
INTEGRA CUSA NXT INFERIOR FOWARD BONE TIP (K113570)Integra Burlington Ma, Inc.2012-02-22
INTEGRA(TM) CUSA NXT(TM) BONE TIPS (K111741)Integra Burlington Ma, Inc. (Formerly Integra Radi2011-08-23
CUSA NXT EXTENDED LENGTH TIP (K102258)Integra Radionics, Inc.2011-06-10
SONICISION CORDLESS ULTRASONIC DISSECTION DEVICE MODEL SCD391, SCD396, SCT12, SCG, SCB, SCSK, SONICISION STERILIZATION T (K101797)Covidien, Formerly Valleylab, A Division of Tyco2011-02-24
TX1 TISSUE REMOVAL SYSTEM (K101561)American Optisurgical, Inc.2010-08-27
HARMONIC FOCUS SHEARS (K100597)Ethicon Endo-Surgery, LLC2010-04-07
CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K090864)Integra Radionics, Inc.2009-05-08
CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM (K081459)Integra Radionics, Inc.2008-08-13
SONOCA 180/195 WOUND CARE SYSTEM (K072904)Soering GmbH2008-05-21
HARMONIC 10CM COMBINATION HOOK BLADE (K072203)Ethicon Endo-Surgery, LLC2007-09-25
INTEGRA SELECTOR ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE TIP (K071669)Integra Radionics, Inc.2007-08-17
KIRWAN DISPOSABLE 23KHZ MANIFOLD TUBING, 40-3600, & 36KHZ MANIFOLD TUBING, 40-3601 (K070360)Kirwan Surgical Products, Inc.2007-08-07
MISONIX, INC., AUSS-7 ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K070313)Misonix, Inc.2007-05-11
SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM (K063531)Sra Developments, Ltd.2007-02-22
HARMONIC FOCUS CURVED SHEARS AND TORQUE WRENCH, HARMONIC BLUE HAND PIECE AND TEST TIP (K063192)Ethicon Endo-Surgery, LLC2007-01-30
AR1000 ULTRASONIC WOUND THERAPY SYSTEM (K062544)Arobella Medical, LLC2007-01-03
ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL FS 1000 RF (K062471)Misonix, Inc.2006-10-26
HARMONIC WAVE COAGULATING SHEARS WITH SCISSOR HANDEL AND HAND CONTROL, MODEL WAVE18S; HARMONIC DISPOSABLE TORQUE WRENCH (K062000)Ethicon Endo-Surgery, Inc.2006-09-25
HARMONIC SCALPEL BLADES AND SHEARS (K060245)Ethicon Endo-Surgery, Inc.2006-04-07
HARMONIC SCALPEL BLADES AND SHEARS (K053056)Ethicon Endo-Surgery, Inc.2006-01-19
RADIONICS CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM WITH BONE (K051947)Radionics, A Division of Tyco Healthcare Group LP2005-08-22
AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K050776)Misonix, Inc.2005-06-06
OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG (K050885)Olympus Medical Systems Corporation2005-06-03
HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P (K051036)Ethicon Endo-Surgery, Inc.2005-06-02
SONOSURG TROCAR (K042160)Aomori Olympus Co., Ltd.2005-01-25
HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P (K042777)Ethicon Endo-Surgery, Inc.2004-12-01
SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM (K042277)Integra Neurosciences, Ltd.2004-09-29
SONOSURG ULTRASONIC SURGICAL SYSTEM (K041566)Aomori Olympus Co., Ltd.2004-09-08
LOTUS (K032424)Sra Developments, Ltd.2003-12-16
MISONIX INC. FS 1000 RF ULTRASONIC SURGICAL ASPIRATOR SYSTEM (K032690)Misonix, Inc.2003-12-09
SONOSURG SYSTEM (K032066)The Olympus Optical Co.2003-10-03
OLYMPUS ULTRASONIC SURGICAL SYSTEM (K031523)Aomori Olympus Co., Ltd.2003-10-01
OLYMPUS ULTRASONIC SURGICAL SYSTEM (K031305)Olympus Optical Co., Ltd.2003-09-23
OLYMPUS ULTRASONIC SURGICAL SYSTEM (K031710)Aomori Olympus Co., Ltd.2003-08-29
OLYMPUS ULTRASONIC SURGICAL SYSTEM (K021962)The Olympus Optical Co.2003-02-12
SELECTOR INTEGRA ULTRASONIC SURGICAL ASPIRATOR, MODEL OM 1530000M3 (K021989)Integra Neurosciences2002-09-13
AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM (K021929)Axya Medical, Inc.2002-09-10
ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE (K020220)Synergetics, Inc.2002-08-23
SORING GMBH SONOCA 180/190 (K012753)Soring GmbH Medizintechnik2001-11-13
ULTRACISION HARMONIC SCALPEL BLADES WITH PROTECTIVE SLEEVE, MODELS DH105, DH145, SH105, SH145 (K012176)Ethicon Endo-Surgery, Inc.2001-10-01
ALLIGER ULTRASONIC SURGICAL SYSTEM MODEL AUSS-5 (K012028)Misonix, Inc.2001-07-27
ULTRACISION HARMONIC SCALPEL BLADES, MODEL DH105,DH145,SH105, SH145,HC145 (K010898)Ethicon Endo-Surgery, Inc.2001-05-31
SONOTOME ULTRASONIC ASPIRATOR TIPS (K010637)Synergetics, Inc.2001-04-20
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