ClearanceBrief
Product code LFL ยท 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)
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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
DateFirm and productCodeLinked 510(k)
Apr 17, 2026Integra LifeSciences Corp. (NeuroSciences)
CUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.
Open, Classified		 LFLK161882
Feb 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
Open, Classified		 LFLK111202
Feb 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
Open, Classified		 LFLK111202
Feb 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Open, Classified		 LFLK111202
Feb 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
Open, Classified		 LFLK111202
Feb 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Open, Classified		 LFLK111202
Feb 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Open, Classified		 LFLK111202
Feb 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Open, Classified		 LFLK111202
Feb 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Open, Classified		 LFLK111202
Feb 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Open, Classified		 LFLK111202
Feb 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Open, Classified		 LFLK172610
Feb 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Open, Classified		 LFLK172610
Feb 17, 2026Olympus Corporation of the Americas
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Open, Classified		 LFLK172610
Jan 21, 2025Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat, 5MM, 35CM, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N5423
Open, Classified		 LFLK211838
Jan 21, 2025Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5424
Open, Classified		 LFLK211838
Jan 21, 2025Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N5423
Open, Classified		 LFLK211838
Jan 21, 2025Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N542351
Open, Classified		 LFLK211838
Jan 21, 2025Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N542343
Open, Classified		 LFLK211838
Jan 21, 2025Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,45 cm,Front-actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: N54233
Open, Classified		 LFLK211838
Jan 21, 2025Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm ,Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N54236
Open, Classified		 LFLK211838
Jan 21, 2025Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: N54237
Open, Classified		 LFLK211838
Jan 21, 2025Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm,20 cm, Front-actuated Grip Type S Model Number: TB-0520FCS Catalog Number/Product Code: N54240
Open, Classified		 LFLK211838
Jan 21, 2025Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: Thunderbeat Front-Actuated Grip Type S Model Number: TB-0545FCS Catalog Number/Product Code: R5000688 Software
Open, Classified		 LFLK211838
Jan 21, 2025Olympus Corporation of the Americas
Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product Name: THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S Model Number: TB-0535FCS Catalog Number/Product Code: R5000
Open, Classified		 LFLK211838
Jun 21, 2024Integra LifeSciences Corp.
CUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue Catalog Number: C2600* *Note: you may see
Open, Classified		 LFLK141674
Oct 12, 2023Olympus Corporation of the Americas
THUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, tho
Open, Classified		 LFLK211838
Oct 12, 2023Olympus Corporation of the Americas
THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, th
Open, Classified		 LFLK211838
Nov 12, 2021Covidien Llc
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Open, Classified		 LFLK180149
Jul 20, 2021Ethicon Endo-Surgery Inc
HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
Open, Classified		 LFLK191555
Jul 20, 2021Ethicon Endo-Surgery Inc
HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20
Open, Classified		 LFLK191555
Jun 23, 2021Covidien Llc
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
Terminated		 LFLK180149
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809
Oct 21, 2019Integra LifeSciences Corp.
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Terminated		 LFLK182809

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