Skip to content
Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances
  • 510(k)K130087Substantially equivalent (SESE) · 2014-01-10clearance family
Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2020-01-06VAIVoluntary action indicatedGynex Corporation6
2020-01-06VAIVoluntary action indicatedGynex Corporation6
2016-05-27VAIVoluntary action indicatedGynex Corporation6
2016-05-27VAIVoluntary action indicatedGynex Corporation6
2014-04-25VAIVoluntary action indicatedGynex Corporation2
2014-04-25VAIVoluntary action indicatedGynex Corporation2
2012-09-21NAINo action indicatedGynex Corporation0
2012-09-21NAINo action indicatedGynex Corporation0
2012-07-20VAIVoluntary action indicatedGynex Corporation2
2012-07-20VAIVoluntary action indicatedGynex Corporation2
Similar devices
Select up to two to place side-by-side with this device.