17 results
·
51ms
·
Sources: EU EUDAMED, US FDA
EZLASE SOFT TISSUE DENTAL LASER
FDA Adverse Event
Malfunction
·BIOLASE TECHNOLOGY, INC.·Product code GEX·December 28, 2007
WATERLASE MD SOFT AND HARD TISSUE LASER
FDA Adverse Event
Other
·BIOLASE TECHNOLOGY, INC.·Product code GEX·December 9, 2008
LASERWHITE 20 WHITENING GEL
FDA Adverse Event
Injury
·BIOLASE TECHNOLOGY, INC.·Product code GEX·February 8, 2011
DIOLASE PLUS
FDA Adverse Event
Other
·BIOLASE TECHNOLOGY, INC.·Product code GEX·October 31, 2006
DIOLASE PLUS
FDA Adverse Event
Injury
·BIOLASE TECHNOLOGY, INC.·Product code GEX·March 28, 2005
LASERWHITE 20 WHITENING GEL
FDA Adverse Event
Malfunction
·BIOLASE TECHNOLOGY, INC.·Product code GEX·October 19, 2011
LASERSMILE
FDA Adverse Event
Other
·BIOLASE TECHNOLOGY, INC.·Product code GEX·March 30, 2009
Waterlase MD, dental laser unit, Model #6200218, serial numbers 10500210 to 105202680, inclusive.
FDA Recall
Terminated
·Biolase Technology Inc·Product code LYB·January 17, 2005
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
FDA Recall
Terminated
·Biolase Technology Inc·Product code GEX·June 12, 2014
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
FDA Enforcement
Class II
·Terminated·Biolase Technology Inc·August 27, 2014
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