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)
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
DateFirm and productCodeLinked 510(k)
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
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
May 3, 2018Ethicon Endo-Surgery Inc
HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE Shears + Adaptive Tissue Technology are
Terminated		 LFLK121550
May 3, 2018Ethicon Endo-Surgery Inc
HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE Shears + Adaptive Tissue Technology are
Terminated		 LFLK121550
Sep 26, 2017Integra LifeSciences Corp.
Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System,
Terminated		 LFLK161882
Apr 13, 2016Stryker Instruments Div. of Stryker Corporation
Spetzler Claw Tip, Universal - 5450-800-311 Spetzler Open Angle Micro Claw Tip, Universal - 5450-800-313 The Spetzler Claw" Tips are bone cutting tips which are a part of Strykers Neuro Spine Ear,
Terminated		 LFLK020220
Nov 16, 2015Ethicon Endo-Surgery Inc
HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45cm length), Ethicon Endo-Surgery. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are
Terminated		 LFLK132612
Dec 1, 2014Integra LifeSciences Corp.
Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgical Aspirator system. One of the tubing lumen transmits irrigation
Terminated		 LFLK081459
Aug 7, 2014Stryker Instruments Div. of Stryker Corporation
Sonopet Ultrasonic Surgical System Console, Ultrasonic Aspirator, Stryker Medtech.
Terminated		 LFLK010309
May 6, 2014Tenex Health Inc
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft
Terminated		 LFLK123640
Apr 29, 2014Integra LifeSciences Corp.
Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA Excel+ Sterile 23 kHz Torque Wrench is an accessory used with the CUSA Excel+ System ultrasonic surgical instrument. The torque wr
Terminated		 LFLK981262
Aug 8, 2013American Optisurgical Inc
TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation
Terminated		 LFLK101561
Aug 6, 2013Stryker Instruments Div. of Stryker Corporation
Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of
Terminated		 LFLK010309
Aug 6, 2013Stryker Instruments Div. of Stryker Corporation
Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiration of
Terminated		 LFLK010309
Aug 6, 2013Stryker Instruments Div. of Stryker Corporation
Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is indicated for use in surgical procedures where fragmentation, emulsification, and aspiratio
Terminated		 LFLK010309
Jun 7, 2013American Optisurgical Inc
TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft t
Terminated		 LFLNone listed
Jun 6, 2013American Optisurgical Inc
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
Terminated		 LFLK101561
Dec 17, 2012Arobella Medical, LLC
Arobella Medical 6mm Qurette used with the Arobella Medical AR1000 Wound Therapy System. Major components of the AR1000 Wound Therapy System include an ultrasonic generator, converter hand piece, do
Terminated		 LFLK062544
May 25, 2012Ethicon Endo-Surgery Inc
HPBLUE: HARMONIC Blue Hand Piece; HP054: HARMONIC Hand Piece; Non-Sterile products are individually packed in a poly bag and then placed into an individual carton. Mfr. By: Ethicon Endo-Surgery, LLc,
Terminated		 LFLK063192
Mar 21, 2012Ethicon Endo-Surgery Inc
ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw, Model # NSLG2S35. Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969 The ENSEAL G2 Tissue Sealers are indicated for b
Terminated		 LFLK112033
Mar 21, 2012Ethicon Endo-Surgery Inc
ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw, Model # NSLG2S14 and ENSEAL 5 mm Diameter Tissue Sealer G2 25 cm Length Straight Jaw, Model # NSLG2S25. Ethicon Endo-Surgery, LLC Guay
Terminated		 LFLK112033
Mar 21, 2012Ethicon Endo-Surgery Inc
ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw, Model # NSLG2C35 and ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 45 cm Length Curved Jaw, Model # NSLG2C45. Ethicon
Terminated		 LFLK112033
Mar 15, 2012Integra LifeSciences Corp
Integra CUSA EXcel Sterile Tips Rx Only Single Use Only Product Usage: For usage in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is des
Terminated		 LFLK981262
Jun 17, 2011Integra Limited
Integra CUSA NXT Ultrasonic Tissue Ablation System Service Module The CUSA NXT Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation. emulsification and
Terminated		 LFLK081459
Oct 1, 2010Stryker Instruments Div. of Stryker Corporation
Sonopet Ultrasonic Surgical System, Model UST-2001, Manufacturer Miwatec Co. LTD, Tokyo, Japan.
Terminated		 LFLNone listed
Sep 30, 2010Integra LifeSciences Corp.
Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT2: Latex Free, Rx only. Integra LifeSciences (Ireland) Limited County Offaly, Ireland Distributed by Integra Lifesciences Corporatio
Terminated		 LFLK081459
Sep 30, 2010Integra LifeSciences Corp.
Integra CUSA Ultrasonics NXT Ultra Surgical Aspirator System CUSANXT1:Latex Free, Rx only: Integra LifeSciences (Ireland) Limited, County Offaly, Ireland; Distributed by Integra Life Sciences Corporat
Terminated		 LFLK081459
Jan 24, 2006Integra LifeSciences Corp.
Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.
Terminated		 LFLK021989
Nov 16, 2005Integra LifeSciences Corp.
Selector Ultrasonic Integra Ultrasonic Aspirator System, Model 1523211 and 1523215, 24kHz Neuro Short Sterile Tip Set.
Terminated		 LFLK021989

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