Instrument, Ultrasonic Surgical
FDA product code LFL · Unclassified · General, Plastic Surgery
158510(k) clearances
0PMA approvals
98recalls
Manufacturers
- Ethicon Endo-Surgery, Inc. 29
- Integra LifeSciences Corp. 13
- Misonix, Inc. 11
- Valleylab, Inc. 9
- The Olympus Optical Co. 5
- Integra Radionics, Inc. 4
- Sra Developments, Ltd. 4
- Covidien LLC 4
- Aomori Olympus Co., Ltd. 4
- Holl Meditronics, Inc. 3
- Olympus Medical Systems Corp. 3
- Stryker Corporation 3
- Tenex Health, Inc. 3
- Niic U.S.A., Inc. 2
- Sharplan Lasers, Inc. 2
- Synergetics Inc 2
- Fibra Sonics, Inc. 2
- Sound Surgical Technologies, LLC 2
- Omnisonics Medical Technologies 2
- Mentor Corp. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261448 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | Misonix, LLC | 07/30/2026SE |
| K251162 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 10/08/2025SE |
| K242894 | SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile Ultrasonic…LFL · Traditional | Shanghai Saints Sages Surgical Co., Ltd. | 06/18/2025SE |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000)LFL · Traditional | Stryker Instruments | 03/24/2025SE |
| K241700 | Tenex 2nd Generation SystemLFL · Traditional | Trice Medical, Inc. | 11/18/2024SE |
| K240493 | CUSA® Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 07/11/2024SE |
| K233036 | Ultrasonic Surgical SystemLFL · Traditional | Hunan Handlike Minimally Invasive Surgery Co.… | 06/18/2024SE |
| K230427 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 07/11/2023SE |
| K231117 | neXus Ultrasonic Surgical Aspirator SystemLFL · Special | Misonix, LLC, A Bioventus Company | 06/23/2023SE |
| K221790 | HARMONIC 700 ShearsLFL · Traditional | Ethicon Endo-Surgery, LLC | 02/28/2023SE |
| K223770 | Sonopet 1Q 3 7cm 1Q LargeLFL · Traditional | Stryker Corporation | 02/16/2023SE |
| K221102 | LOTUS Series 4 Enhanced Shears, LOTUS Series 5LFL · Traditional | Sra Developments, Ltd. | 12/15/2022SE |
| K210567 | Ultrasonic Surgical SystemLFL · Traditional | Miconvey Technologies Co., Ltd. | 09/30/2022SE |
| K221835 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 08/22/2022SE |
| K221235 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | Misonix, Inc. | 07/28/2022SE |
| K212614 | Ultrasonic Scalpel SystemLFL · Traditional | Surgnova Healthcare Technologies (Zhejiang) Co.… | 07/18/2022SE |
| K221763 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Special | Integra LifeSciences Corporation | 07/15/2022SE |
| K212049 | Oclet TDS 1000LFL · Traditional | Tendonova Corporation | 03/08/2022SE |
| K213824 | Sonopet iQ Ultrasonic Aspirator SystemLFL · Special | Stryker Corporation | 02/03/2022SE |
| K212060 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | Misonix, Inc. | 12/13/2021SE |
| K212301 | Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceLFL · Traditional | Covidien, LLC | 11/15/2021SE |
| K212750 | Ultrasonic Surgical Aspirator System, Model: XD880BLFL · Special | Smtp Technology Co., Ltd. | 09/27/2021SE |
| K211838 | Ultrasonic Bipolar Generator USG-410 with accessoriesLFL · Traditional | Olympus Medical Systems Corporation | 08/04/2021SE |
| K211273 | Harmonic Hand Piece, Blue, Harmonic Hand Piece, GrayLFL · Special | Ethicon Endo-Surgery, LLC | 05/21/2021SE |
| K202299 | Ultrasonic Surgical Aspirator SystemLFL · Traditional | Smtp Technology Co., Ltd. | 05/21/2021SE |
| K200427 | Sonicision Cordless Ultrasonic DissectorLFL · Special | Covidien, LLC | 07/10/2020SE |
| K200774 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 06/23/2020SE |
| K192963 | Kogent Torus Ultrasonic AspiratorLFL · Traditional | Katalyst Surgical, LLC | 06/19/2020SE |
| K191555 | HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm lengthLFL · Traditional | Ethicon Endo-Surgery, LLC | 02/28/2020SE |
| K190281 | Ultrasonic Surgical SystemLFL · Abbreviated | Medisonic Technology CO | 10/31/2019SE |
| K190160 | neXus Ultrasonic Surgical Aspirator SystemLFL · Traditional | Misonix, Inc. | 05/30/2019SE |
| K190070 | Sonopet iQ Ultrasonic Aspirator SystemLFL · Traditional | Stryker Corporation | 04/11/2019SE |
| K190180 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 04/01/2019SE |
| K182809 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 12/07/2018SE |
| K181367 | Tenex Health TX System with the TXP MicroTipLFL · Traditional | Tenex Health, Inc. | 08/28/2018SE |
| K180149 | Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…LFL · Traditional | Covidien, LLC | 03/26/2018SE |
| K172691 | Ultrasonic GeneratorLFL · Special | Olympus Medical Systems Corp. | 10/04/2017SE |
| K172595 | CUSA Excel+ Ultrasonic Surgical Aspirator SystemLFL · Special | Integra LifeSciences Corporation | 09/28/2017SE |
| K161882 | CUSA Clarity Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 10/14/2016SE |
| K160752 | HARMONIC HD 1000i Shears 20 cm Length, HARMONIC HD 1000i Shears 36 cm LengthLFL · Traditional | Ethicon Endo-Suregery, LLC | 06/29/2016SE |
| K153371 | Sonicision Cordless Ultrasonic Dissection DeviceLFL · Traditional | Covidien, LLC | 03/28/2016SE |
| K151136 | Harmonic HookLFL · Traditional | Ethicon Endo-Surgery, LLC | 03/04/2016SE |
| K153299 | Tenex Health TX SystemLFL · Traditional | Tenex Health, Inc. | 03/03/2016SE |
| K150682 | CUSA Excel+LFL · Traditional | Integra Lifesciences Corp. | 12/18/2015SE |
| K151101 | Lotus Series 4 Ultrasonic Surgical System & AccessoriesLFL · Special | Sra Developments, Ltd. | 07/17/2015SE |
| K151340 | HARMONIC Focus Long Shears + Adaptive Tissue TechnologyLFL · Special | Ethicon Endo-Surgery, LLC | 07/10/2015SE |
| K150271 | Prime Adaptive Ultrasonic Scalpel SystemLFL · Traditional | Endoprime, Inc. | 05/29/2015SE |
| K141674 | Cusa Excel+ Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 11/06/2014SE |
| K141668 | Cusa Excel+ Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra LifeSciences Corporation | 11/06/2014SE |
| K141371 | Sonicision Cordless Ultrasonic DissectorLFL · Special | Covidien, Formerly Valleylab, A Division of Tyco H | 08/07/2014SE |
| K132522 | Harmonic Ace Curved Shears with Ergonomic HandleLFL · Traditional | Ethicon Endo-Surgery, LLC | 12/16/2013SE |
| K133314 | Harmonic Focus Shears + Adaptive Tissue TechnologyLFL · Traditional | Ethicon Endo-Surgery, LLC | 12/03/2013SE |
| K132512 | Harmonic Ace Curved Shears with Scissor Handle, Harmonic Ace Curved Shears with…LFL · Special | Ethicon Endo-Surgery, LLC | 10/24/2013SE |
| K132612 | Harmonic Ace+ Shears 23 CM Length with Advanced Hemostasis, Harmonic Ace + Laparoscopic…LFL · Traditional | Ethicon Endo-Surgery, LLC | 10/17/2013SE |
| K123640 | TX1 Tissue Removal SystemLFL · Traditional | Tenex Health | 03/20/2013SE |
| K121550 | Harmonic Ace Laparoscopic 5MM Diameter Shears 36CM Length + Adaptive Tissue TechnologyLFL · Traditional | Ethicon Endo-Surgery, LLC | 08/22/2012SE |
| K120729 | Haronis Ace Laparoscopic 5MM Diameter Shears 36CM Length +Adaptive Tissue Technology…LFL · Traditional | Ethicon Endo-Surgery, LLC | 05/17/2012SE |
| K113570 | Integra Cusa NXT Inferior Foward Bone TipLFL · Traditional | Integra Burlington Ma, Inc. | 02/22/2012SE |
| K111741 | Integra(Tm) Cusa Nxt(Tm) Bone TipsLFL · Traditional | Integra Burlington Ma, Inc. (Formerly Integra Radi | 08/23/2011SE |
| K102258 | Cusa NXT Extended Length TipLFL · Traditional | Integra Radionics, Inc. | 06/10/2011SE |
| K101797 | Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB…LFL · Traditional | Covidien, Formerly Valleylab, A Division of Tyco | 02/24/2011SE |
| K101561 | TX1 Tissue Removal SystemLFL · Traditional | American Optisurgical, Inc. | 08/27/2010SE |
| K100597 | Harmonic Focus ShearsLFL · Traditional | Ethicon Endo-Surgery, LLC | 04/07/2010SE |
| K090864 | Cusa Shear Tip, an Accessory of the Cusa Excel Ultrasonic Surgical Aspirator SystemLFL · Traditional | Integra Radionics, Inc. | 05/08/2009SE |
| K081459 | Cusa Selector NXT Ultrasonic Tissue Ablation SystemLFL · Traditional | Integra Radionics, Inc. | 08/13/2008SE |
| K072904 | Sonoca 180/195 Wound Care SystemLFL · Traditional | Soering GmbH | 05/21/2008SE |
| K072203 | Harmonic 10CM Combination Hook BladeLFL · Traditional | Ethicon Endo-Surgery, LLC | 09/25/2007SE |
| K071669 | Integra Selector Ultrasonic Surgical Aspirator System with Bone TipLFL · Traditional | Integra Radionics, Inc. | 08/17/2007SE |
| K070360 | Kirwan Disposable 23KHZ Manifold Tubing, 40-3600, & 36KHZ Manifold Tubing, 40-3601LFL · Traditional | Kirwan Surgical Products, Inc. | 08/07/2007SE |
| K070313 | Misonix, Inc., AUSS-7 Ultrasonic Surgical Aspirator SystemLFL · Special | Misonix, Inc. | 05/11/2007SE |
| K063531 | Series 3 Lotus Laparoscopic Ultrasound Surgery SystemLFL · Traditional | Sra Developments, Ltd. | 02/22/2007SE |
| K063192 | Harmonic Focus Curved Shears and Torque Wrench, Harmonic Blue Hand Piece and Test TipLFL · Traditional | Ethicon Endo-Surgery, LLC | 01/30/2007SE |
| K062544 | AR1000 Ultrasonic Wound Therapy SystemLFL · Traditional | Arobella Medical, LLC | 01/03/2007SE |
| K062471 | Ultrasonic Surgical Aspirator System, Model FS 1000 RFLFL · Traditional | Misonix, Inc. | 10/26/2006SE |
| K062000 | Harmonic Wave Coagulating Shears with Scissor Handel and Hand Control, Model WAVE18S…LFL · Traditional | Ethicon Endo-Surgery, Inc. | 09/25/2006SE |
| K060245 | Harmonic Scalpel Blades and ShearsLFL · Traditional | Ethicon Endo-Surgery, Inc. | 04/07/2006SE |
| K053056 | Harmonic Scalpel Blades and ShearsLFL · Traditional | Ethicon Endo-Surgery, Inc. | 01/19/2006SE |
| K051947 | Radionics Cusa Excel Ultrasonic Surgical Aspirator System with BoneLFL · Traditional | Radionics, A Division of Tyco Healthcare Group LP | 08/22/2005SE |
| K050776 | AUSS-6 Ultrasonic Surgical Aspirator SystemLFL · Traditional | Misonix, Inc. | 06/06/2005SE |
| K050885 | Olympus Ultrasonic Surgical System SonosurgLFL · Traditional | Olympus Medical Systems Corporation | 06/03/2005SE |
| K051036 | Harmonic Ace Curved Shears with Pistol Handle and Hand Control, Model ACE23P, ACE36PLFL · Traditional | Ethicon Endo-Surgery, Inc. | 06/02/2005SE |
| K042160 | Sonosurg TrocarLFL · Traditional | Aomori Olympus Co., Ltd. | 01/25/2005SE |
| K042777 | Harmonic Ace Curved Shears with Hand Control, Model ACE23P, ACE36PLFL · Traditional | Ethicon Endo-Surgery, Inc. | 12/01/2004SE |
| K042277 | Selector Quantum Ultrasonic Aspirator SystemLFL · Traditional | Integra Neurosciences, Ltd. | 09/29/2004SE |
| K041566 | Sonosurg Ultrasonic Surgical SystemLFL · Traditional | Aomori Olympus Co., Ltd. | 09/08/2004SE |
| K032424 | LotusLFL · Traditional | Sra Developments, Ltd. | 12/16/2003SE |
| K032690 | Misonix Inc. FS 1000 RF Ultrasonic Surgical Aspirator SystemLFL · Traditional | Misonix, Inc. | 12/09/2003SE |
| K032066 | Sonosurg SystemLFL · Traditional | The Olympus Optical Co. | 10/03/2003SE |
| K031523 | Olympus Ultrasonic Surgical SystemLFL · Traditional | Aomori Olympus Co., Ltd. | 10/01/2003SE |
| K031305 | Olympus Ultrasonic Surgical SystemLFL · Traditional | Olympus Optical Co., Ltd. | 09/23/2003SE |
| K031710 | Olympus Ultrasonic Surgical SystemLFL · Traditional | Aomori Olympus Co., Ltd. | 08/29/2003SE |
| K021962 | Olympus Ultrasonic Surgical SystemLFL · Traditional | The Olympus Optical Co. | 02/12/2003SE |
| K021989 | Selector Integra Ultrasonic Surgical Aspirator, Model Om 1530000M3LFL · Traditional | Integra Neurosciences | 09/13/2002SE |
| K021929 | Axya Medical, Inc, Model 100 Sonic Scalpel Ultrasonic Surgical SystemLFL · Traditional | Axya Medical, Inc. | 09/10/2002SE |
| K020220 | Ultrasonic Straight/Ultrasonic Knife/Ultrasonic Ring CurretteLFL · Traditional | Synergetics, Inc. | 08/23/2002SE |
| K012753 | Soring GmbH Sonoca 180/190LFL · Traditional | Soring GmbH Medizintechnik | 11/13/2001SE |
| K012176 | Ultracision Harmonic Scalpel Blades with Protective Sleeve, Models DH105, DH145, SH105…LFL · Traditional | Ethicon Endo-Surgery, Inc. | 10/01/2001SE |
| K012028 | Alliger Ultrasonic Surgical System Model AUSS-5LFL · Special | Misonix, Inc. | 07/27/2001SE |
| K010898 | Ultracision Harmonic Scalpel Blades, Model DH105,DH145,SH105, SH145,HC145LFL · Traditional | Ethicon Endo-Surgery, Inc. | 05/31/2001SE |
| K010637 | Sonotome Ultrasonic Aspirator TipsLFL · Traditional | Synergetics, Inc. | 04/20/2001SE |
| K010309 | Sonopet Model UST-2001 Ultrasonic Surgical AspiratorLFL · Traditional | Mutoh America Co., Ltd. | 04/18/2001SE |
| K003824 | Omnisonics Ultrasonic Surgery System, Model StiLFL · Traditional | Omnisonics Medical Technologies | 03/08/2001SE |
| K002906 | Ultracision Harmonic Scalpel System, Models GEN01, GEN02, GEN03, HP052, HP053, HSA07LFL · Traditional | Ethicon Endo-Surgery, Inc. | 12/15/2000SE |
| K000927 | Alliger Ultrasonic Surgical System Model AUSS-4LFL · Traditional | Misonix, Inc. | 10/10/2000SE |
| K000095 | Olympus Sonosurg Trocar XT3900 SystemLFL · Traditional | The Olympus Optical Co. | 09/26/2000SE |
| K994280 | Ultracision Harmonic Scalpel Sharp Curved Blade/Fast Blade, Model HF105LFL · Traditional | Ethicon Endo-Surgery, Inc. | 03/17/2000SE |
| K993868 | The Soundvaser Dissection SystemLFL · Traditional | Sound Surgical Technologies, LLC | 12/21/1999SE |
| K993628 | Omnisonics Ultrasonic ProbesLFL · Traditional | Omnisonics Medical Technologies | 12/15/1999SE |
| K993054 | Ultracision Harmonic Scalpel Coagulating Shears, Models LCS-C5, LCS-C1, CS-23C, CS-231…LFL · Traditional | Ethicon Endo-Surgery, Inc. | 12/09/1999SE |
| K991791 | Sound Vaser SystemLFL · Traditional | Sound Surgical Technologies, LLC | 08/12/1999SE |
| K990572 | SonotomeLFL · Traditional | Sonokinetics, Inc. | 05/21/1999SE |
| K990430 | Ultracision Harmonic Scalpel Hand PieceLFL · Special | Ethicon Endo-Surgery, Inc. | 03/12/1999SE |
| K983199 | Fibra Sonics Ultrasonic Surgical Aspirator System, Model 1000 Console ModelLFL · Traditional | Fibra Sonics, Inc. | 12/14/1998SE |
| K983065 | Mentor Ultrasound-Assisted Tissue Removal SystemLFL · Traditional | Mentor Corp. | 12/01/1998SE |
| K980895 | Allegro Ultrasonic Soft Tissue AspiratorLFL · Traditional | California Institute of Tissue Eng. & Instrumenti | 11/06/1998SE |
| K983316 | Ultracision 5MM InstrumentsLFL · Special | Ethicon Endo-Surgery, Inc. | 10/21/1998SE |
| K980930 | Fibra Sonics Ultrasonic Surgical Aspirator System, Model 2100 UsstaLFL · Traditional | Fibra Sonics, Inc. | 09/22/1998SE |
| K982841 | Modification to Alliger Ultrasonic Surgical System, Model AUSS-4LFL · Special | Misonix, Inc. | 09/04/1998SE |
| K981262 | Cusa Excel Ultrasonic Surgical Aspirator SystemLFL · Traditional | Valleylab, Inc. | 07/06/1998SE |
| K972114 | Olympus Sonosurg SystemLFL · Traditional | The Olympus Optical Co. | 05/18/1998SE |
| K980099 | Ultracision Laparosonic Coagulating Shears (LCS-5(LCSK5 and LCSB5))LFL · Traditional | Ethicon Endo-Surgery, Inc. | 04/09/1998SE |
| K972148 | B.U.S. EndotronLFL · Traditional | Medicamat S.A. | 12/10/1997SE |
| K971580 | Uas Ultrasonic Aspirator SystemLFL · Traditional | Wells Johnson Co. | 12/09/1997SE |
| K971609 | SculptureLFL · Traditional | Servizi Medico Estetici Italinai Srl. | 08/14/1997SE |
| K971533 | Vibra-Surge System Model VS2120LFL · Traditional | Sonics & Materials, Inc. | 07/25/1997SE |
| K970471 | Mentor Ultrasound Assisted Tissue Removal System (TRS)LFL · Traditional | Mentor Corp. | 07/17/1997SE |
| K971302 | Ultracision 5MM Laparosonic Hook Blades, Ultracision HS2 BladeLFL · Traditional | Ethicon Endo-Surgery, Inc. | 07/07/1997SE |
| K971861 | Ultrasonic Hand InstrumentsLFL · Traditional | United States Surgical, A Division of Tyco Healthc | 07/01/1997SE |
| K964742 | Ronix II Rotary Ultrasonic Surgical SystemLFL · Traditional | Aziz Y. Anis, M.D. | 04/22/1997SE |
| K964601 | Cusa System 200C Ultrasonic Aspirator/Cusa System 200T Ultrasonic Aspirator/Cusa Lap…LFL · Traditional | Valleylab, Inc. | 01/16/1997SE |
| K962584 | Ultracision 5MM Hard Sheath Laparosonic BladeLFL · Traditional | Ethicon Endo-Surgery, Inc. | 11/04/1996SE |
| K962525 | Ultra-Safe Ultrasonic Aspirator SystemLFL · Traditional | Morwel Corp. | 09/19/1996SE |
| K960374 | Ultracut 2000LFL · Traditional | Ultralase Technologies, Inc. | 06/28/1996SE |
| K960040 | Sharplan Ultra Laparoscopic HandpieceLFL · Traditional | Sharplan Lasers, Inc. | 04/29/1996SE |
| K934628 | Cusa(R) Syst 200CT/200T Ultra Aspir Lap/Cem AccessLFL · Traditional | Valleylab, Inc. | 07/11/1995SE |
| K950945 | Cooper Laser Sonics Cusa Model 200LFL · Traditional | Valleylab, Inc. | 04/10/1995SE |
| K942095 | Sonoca IIILFL · Traditional | Holl Meditronics, Inc. | 11/09/1994SE |
| K931902 | Cusa System 200C/T Ultrasonic Aspirator & Access.LFL · Traditional | Valleylab, Inc. | 09/16/1994SE |
| K933559 | Alliger Ultrasonic Surgical SystemLFL · Traditional | Medsonic, Inc. | 10/15/1993SE |
| K933239 | CV720-727-000, Microtip and Flue PakLFL · Traditional | Valleylab, Inc. | 10/12/1993SE |
| K932094 | Bovie Ultrasonic Surgical AspiratorLFL · Traditional | Mdt Corp., Inc. | 07/21/1993SE |
| K921251 | Cusa System 200C and 200T Ultrasonic AspiratorLFL · Traditional | Valleylab, Inc. | 06/12/1992SE |
| K910696 | Cusa(R) System 200C/200T/200M/200H Ultra AspiratorLFL · Traditional | Valleylab, Inc. | 06/11/1991SE |
| K904010 | Surgical Aspirator KitLFL · Traditional | Surgeon Surgical Instrumentation, Inc. | 11/21/1990SE |
| K901974 | Selector Ultrasonic Surgical AspiratorLFL · Traditional | Spembly Medical , Ltd. | 09/05/1990SE |
| K901737 | Sonoca II Ultrasonic Surgical DeviceLFL · Traditional | Holl Meditronics, Inc. | 07/03/1990SE |
| K894600 | Cusa System 200C,T,M,H Ultrasonic AspiratorLFL · Traditional | Valleylab, Inc. | 01/19/1990SE |
| K893926 | Sonoca Ultrasonic Surgical SystemLFL · Traditional | Holl Meditronics, Inc. | 11/14/1989SE |
| K883091 | Sharplan 4300 & 4310 Ultrasonic Surgical ApiratorsLFL · Traditional | Sharplan Lasers, Inc. | 10/14/1988SE |
| K880815 | DX101-T Ultrasonic Surgical SystemLFL · Traditional | Niic U.S.A., Inc. | 04/13/1988SE |
| K880814 | DX101 Ultrasonic Surgical SystemLFL · Traditional | Niic U.S.A., Inc. | 04/13/1988SE |
| K880166 | Bovie Ultrasonic Surgical Aspirator, Model ME2000LFL · Traditional | Clinical Technology Corp. | 02/18/1988SE |
| K864983 | Cusa System 200 Macro-DissectorLFL · Traditional | Cooper Lasersonics, Inc. | 06/23/1987SE |
| K852539 | Suszoi Ultrasonic Surgical Aspirator SonopLFL · Traditional | Johnson & Johnson Professionals, Inc. | 07/23/1985SE |
| K851203 | R PakLFL · Traditional | CooperVision, Inc. | 07/23/1985SE |
| K830753 | Needle Guide Model 21285ALFL · Traditional | Hewlett-Packard Co. | 06/16/1983SE |
| K821820 | MCSC6PS Medical ComponentsLFL · Traditional | Medical Components, Inc. | 07/13/1982SE |
| K801623 | Cavitron Ultrasonic Surg. Aspir. CusaLFL · Traditional | Cavitron Corp. | 11/18/1980SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1828-2026 Class II | CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator…Software issue that renders the touch screen unresponsive. | Integra LifeSciences Corp. (NeuroSciences) | 03/06/2026Open, Classified |
| Z-1382-2026 Class II | Olympus Thunderbeat 5 mm, 10 cm, Inline GripFirm is initiating a removal due to continued reports of adverse events. | Olympus Corporation of the Americas | 10/22/2025Open, Classified |
| Z-1381-2026 Class II | Olympus Thunderbeat, 5 mm, 20 cm, Inline GripFirm is initiating a removal due to continued reports of adverse events. | Olympus Corporation of the Americas | 10/22/2025Open, Classified |
| Z-1380-2026 Class II | Olympus Thunderbeat, 5 mm, 35 cm, Inline GripFirm is initiating a removal due to continued reports of adverse events. | Olympus Corporation of the Americas | 10/22/2025Open, Classified |
| Z-1379-2026 Class II | Olympus Thunderbeat, 5 mm, 45 cm Inline GripFirm is initiating a removal due to continued reports of adverse events. | Olympus Corporation of the Americas | 10/22/2025Open, Classified |
| Z-1378-2026 Class II | Olympus Thunderbeat, 5mm, 35 cm, Pistol GripFirm is initiating a removal due to continued reports of adverse events. | Olympus Corporation of the Americas | 10/22/2025Open, Classified |
| Z-1377-2026 Class II | Olympus Thunderbeat, 5 mm, 45 cm, Pistol GripFirm is initiating a removal due to continued reports of adverse events. | Olympus Corporation of the Americas | 10/22/2025Open, Classified |
| Z-1376-2026 Class II | Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated GripFirm is initiating a removal due to continued reports of adverse events. | Olympus Corporation of the Americas | 10/22/2025Open, Classified |
| Z-1375-2026 Class II | Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated GripFirm is initiating a removal due to continued reports of adverse events. | Olympus Corporation of the Americas | 10/22/2025Open, Classified |
| Z-1374-2026 Class II | Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated GripFirm is initiating a removal due to continued reports of adverse events. | Olympus Corporation of the Americas | 10/22/2025Open, Classified |
| Z-1373-2026 Class II | Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type SFirm is initiating a removal due to continued reports of adverse events. | Olympus Corporation of the Americas | 10/22/2025Open, Classified |
| Z-1372-2026 Class II | Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type SFirm is initiating a removal due to continued reports of adverse events. | Olympus Corporation of the Americas | 10/22/2025Open, Classified |
| Z-1371-2026 Class II | Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type SFirm is initiating a removal due to continued reports of adverse events. | Olympus Corporation of the Americas | 10/22/2025Open, Classified |
| Z-1003-2025 Class II | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name:…The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. | Olympus Corporation of the Americas | 11/25/2024Open, Classified |
| Z-1002-2025 Class II | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name:…The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. | Olympus Corporation of the Americas | 11/25/2024Open, Classified |
| Z-1001-2025 Class II | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name:…The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. | Olympus Corporation of the Americas | 11/25/2024Open, Classified |
| Z-1000-2025 Class II | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name:…The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. | Olympus Corporation of the Americas | 11/25/2024Open, Classified |
| Z-0999-2025 Class II | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name:…The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. | Olympus Corporation of the Americas | 11/25/2024Open, Classified |
| Z-0998-2025 Class II | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name:…The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. | Olympus Corporation of the Americas | 11/25/2024Open, Classified |
| Z-0997-2025 Class II | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name:…The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. | Olympus Corporation of the Americas | 11/25/2024Open, Classified |
| Z-0996-2025 Class II | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name:…The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. | Olympus Corporation of the Americas | 11/25/2024Open, Classified |
| Z-0995-2025 Class II | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name:…The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. | Olympus Corporation of the Americas | 11/25/2024Open, Classified |
| Z-0994-2025 Class II | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name:…The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. | Olympus Corporation of the Americas | 11/25/2024Open, Classified |
| Z-0993-2025 Class II | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name:…The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. | Olympus Corporation of the Americas | 11/25/2024Open, Classified |
| Z-2167-2024 Class II | CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where…Potential for the CUSA Excel 23KHz Straight Handpiece housing to crack, may result in delay of treatment | Integra LifeSciences Corp. | 05/29/2024Open, Classified |
| Z-0109-2024 Class II | THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open…Thunderbeats blue seal button may remain in the engaged position after the button is released and not… | Olympus Corporation of the Americas | 09/12/2023Open, Classified |
| Z-0108-2024 Class II | THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for…Thunderbeats blue seal button may remain in the engaged position after the button is released and not… | Olympus Corporation of the Americas | 09/12/2023Open, Classified |
| Z-0332-2022 Class II | Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery…Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or… | Covidien Llc | 11/12/2021Open, Classified |
| Z-2356-2021 Class II | HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when…An internal component may be cracked and become lodged behind the energy button potentially resulting in… | Ethicon Endo-Surgery Inc | 07/20/2021Open, Classified |
| Z-2355-2021 Class II | HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when…An internal component may be cracked and become lodged behind the energy button potentially resulting in… | Ethicon Endo-Surgery Inc | 07/20/2021Open, Classified |
| Z-2240-2021 Class II | Covidien Sonicision Reusable Generator-converts electrical power from the battery pack…Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device… | Covidien Llc | 06/23/2021Terminated |
| Z-0654-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0653-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0652-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0651-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0650-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0649-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0648-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0647-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0646-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0645-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0644-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0643-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0642-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0641-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0640-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0639-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0638-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0637-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |
| Z-0636-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | Integra LifeSciences Corp. | 10/21/2019Terminated |