9 results
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38ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Recall
Terminated
·American Optisurgical Inc·Product code LFL·April 30, 2013
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
FDA Recall
Terminated
·American Optisurgical Inc·Product code OJU·April 30, 2013
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 12, 2013
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
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 12, 2013
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 tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
FDA Enforcement
Class II
·Terminated·American Optisurgical Inc·June 19, 2013
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 Recall
Terminated
·American Optisurgical Inc·Product code LFL·February 22, 2012
American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery.
FDA Recall
Terminated
·American Optisurgical Inc·Product code HQC·March 24, 2009
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