ClearanceBrief
Product code LFL · Class U

Instrument, Ultrasonic Surgical

3510(k)s in 12 months (160 all time)
13recalls in 12 months (109 all time)
99recalls that name a 510(k)
Get daily alerts for LFLSample briefCSV

Top companies in LFL

Company510(k)sRecalls
Integra LifeSciences Corporation1351
Ethicon Endo-Surgery, Inc.2917
Olympus Corporation of the Americas025
Misonix, Inc.111
Valleylab, Inc.90
Covidien, LLC42
Stryker Instruments Div. of Stryker Corporation06
Olympus Optical Co., Ltd.50
American Optisurgical, Inc.13
Aomori Olympus Co., Ltd.40
Decided510(k)Device and applicantCode
Oct 15, 2026K261361TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORU
Carl Zeiss Meditec, AG, DE
LFL
Oct 8, 2026K262244Sonopet iQ Series III Console (5700-050-000); Sonopet iQ+ Straight Handpiece (5500-260-000); Sonopet iQ+ 10mm iQ+ Blade
Stryker Instruments
LFL
Jul 30, 2026K261448neXus Ultrasonic Surgical Aspirator System
Misonix, LLC
LFL
Oct 8, 2025K251162CUSA® Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
LFL
Jun 18, 2025K242894SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD1
Shanghai Saints Sages Surgical Co., Ltd., CN
LFL
Mar 24, 2025K243930Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
Stryker Instruments
LFL
Nov 18, 2024K241700Tenex 2nd Generation System
Trice Medical, Inc.
LFL
Jul 11, 2024K240493CUSA® Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
LFL
Jun 18, 2024K233036Ultrasonic Surgical System
Hunan Handlike Minimally Invasive Surgery Co., Ltd., CN
LFL
Jul 11, 2023K230427CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
LFL
Jun 23, 2023K231117neXus Ultrasonic Surgical Aspirator System
Misonix, LLC, A Bioventus Company
LFL
Feb 28, 2023K221790HARMONIC 700 Shears
Ethicon Endo-Surgery, LLC
LFL
Feb 16, 2023K223770Sonopet 1Q 3 7cm 1Q Large
Stryker Corporation
LFL
Dec 15, 2022K221102LOTUS Series 4 Enhanced Shears, LOTUS Series 5
Sra Developments, Ltd., GB
LFL
Sep 30, 2022K210567Ultrasonic Surgical System
Miconvey Technologies Co., Ltd., CN
LFL
Aug 22, 2022K221835CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
LFL
Jul 28, 2022K221235neXus Ultrasonic Surgical Aspirator System
Misonix, Inc.
LFL
Jul 18, 2022K212614Ultrasonic Scalpel System
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd., CN
LFL
Jul 15, 2022K221763CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
LFL
Mar 8, 2022K212049Oclet TDS 1000
Tendonova Corporation
LFL
Feb 3, 2022K213824Sonopet iQ Ultrasonic Aspirator System
Stryker Corporation
LFL
Dec 13, 2021K212060neXus Ultrasonic Surgical Aspirator System
Misonix, Inc.
LFL
Nov 15, 2021K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device
Covidien, LLC
LFL
Sep 27, 2021K212750Ultrasonic Surgical Aspirator System, Model: XD880B
Smtp Technology Co., Ltd., CN
LFL
Aug 4, 2021K211838Ultrasonic Bipolar Generator USG-410 with accessories
Olympus Medical Systems Corporation, JP
LFL
May 21, 2021K211273Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray
Ethicon Endo-Surgery, LLC
LFL
May 21, 2021K202299Ultrasonic Surgical Aspirator System
Smtp Technology Co., Ltd., CN
LFL
Jul 10, 2020K200427Sonicision Cordless Ultrasonic Dissector
Covidien, LLC
LFL
Jun 23, 2020K200774CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
LFL
Jun 19, 2020K192963Kogent Torus Ultrasonic Aspirator
Katalyst Surgical, LLC
LFL
Feb 28, 2020K191555HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length
Ethicon Endo-Surgery, LLC
LFL
Oct 31, 2019K190281Ultrasonic Surgical System
Medisonic Technology CO
LFL
May 30, 2019K190160neXus Ultrasonic Surgical Aspirator System
Misonix, Inc.
LFL
Apr 11, 2019K190070Sonopet iQ Ultrasonic Aspirator System
Stryker Corporation
LFL
Apr 1, 2019K190180CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
LFL
Dec 7, 2018K182809CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
LFL
Aug 28, 2018K181367Tenex Health TX System with the TXP MicroTip
Tenex Health, Inc.
LFL
Mar 26, 2018K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), So
Covidien, LLC
LFL
Oct 4, 2017K172691Ultrasonic Generator
Olympus Medical Systems Corp., JP
LFL
Sep 28, 2017K172595CUSA Excel+ Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
LFL
Oct 14, 2016K161882CUSA Clarity Ultrasonic Surgical Aspirator System
Integra LifeSciences Corporation
LFL
Jun 29, 2016K160752HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm Length
Ethicon Endo-Suregery, LLC
LFL
Mar 28, 2016K153371Sonicision Cordless Ultrasonic Dissection Device
Covidien, LLC
LFL
Mar 4, 2016K151136HARMONIC HOOK
Ethicon Endo-Surgery, LLC
LFL
Mar 3, 2016K153299Tenex Health TX System
Tenex Health, Inc.
LFL
Dec 18, 2015K150682CUSA Excel+
Integra Lifesciences Corp.
LFL
Jul 17, 2015K151101Lotus Series 4 Ultrasonic Surgical System & Accessories
Sra Developments, Ltd., GB
LFL
Jul 10, 2015K151340HARMONIC Focus Long Shears + Adaptive Tissue Technology
Ethicon Endo-Surgery, LLC
LFL
May 29, 2015K150271Prime Adaptive Ultrasonic Scalpel System
Endoprime, Inc.
LFL
Nov 6, 2014K141674CUSA EXCEL+ ULTRASONIC SURGICAL ASPIRATOR SYSTEM
Integra LifeSciences Corporation
LFL

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.