8 results
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22ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
FDA Enforcement
Class I
·Terminated·Lumenis Limited·February 20, 2013
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
FDA Enforcement
Class II
·Terminated·Lumenis Limited·November 2, 2016
Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
FDA Enforcement
Class II
·Terminated·Lumenis Limited·May 6, 2015
Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
FDA Enforcement
Class II
·Terminated·Lumenis·September 23, 2015
Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
FDA Recall
Terminated
·Lumenis 13 Hayetzira St., Yokneam Ind. Park Yokneam Israel·Product code GCJ·July 30, 2015
Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
FDA Recall
Terminated
·Lumenis Limited 13 Hayetzira St., Yokneam Ind. Park Yokneam Israel·Product code GEX·March 25, 2015
The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
FDA Recall
Terminated
·Lumenis Limited 13 Hayetzira St., Yokneam Ind. Park Yokneam Israel·Product code GCJ·January 2, 2013
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
FDA Recall
Terminated
·Lumenis Limited 13 Hayetzira St., Yokneam Ind. Park Yokneam Israel·Product code GEX·September 25, 2016