111 results
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19ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 27, 2012
FlexTray Procedure Delivery System Endopath General Laparoscopic Tray, Product #TGL56.
FDA Recall
Terminated
·Ethicon Endo-Surgery·Product code LFL·November 25, 2003
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, 475 Calle C, Guaynbo, PR 00969. Indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code LFL·March 16, 2012
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 desirable.
FDA Recall
Terminated
·Integra LifeSciences Corp·Product code LFL·October 14, 2011
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
Selector Ultrasonic Integra Ultrasonic Aspirator System, Selector 24kHz Microsurgical Sterile Tip Set.
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·November 28, 2005
LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling: MANUFACTURED BY: MISONIX, INC. EXCLUSIVELY FOR SALE BY MENTOR CORPORATION UNDER EXCLUSIVE LICENSE FROM SONIQUE SURGICAL, INC. MISONIX, INC. 1938 NEW HIGHWAY, FARMINGDALE, NY 11735. Device was manufactured from September 1996 to present.
FDA Recall
Terminated
·Misonix, Inc·Product code LFL·August 13, 2003
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
FDA Recall
Terminated
·American Optisurgical Inc·Product code LFL·March 30, 2013
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 Endo-Surgery, LLC Guaynabo, Puerto Rico 00969 The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.
FDA Recall
Terminated
·Ethicon Endo-Surgery Inc·Product code LFL·January 26, 2012
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
FDA Recall
Terminated
·Integra LifeSciences Corp.·Product code LFL·October 21, 2019