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

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2017-03-31NAINo action indicatedMedivators Inc0
2015-05-12VAIVoluntary action indicatedMedivators, Inc.4
2014-07-31NAINo action indicatedMedivators, Inc.0
2012-12-17VAIVoluntary action indicatedMedivators Inc7
2011-08-26VAIVoluntary action indicatedMedivators, Inc.0
2010-07-12VAIVoluntary action indicatedMedivators, Inc.3
2010-06-04VAIVoluntary action indicatedMedivators, Inc.4
2010-04-13VAIVoluntary action indicatedMedivators Inc9
2009-07-31WLWarning LetterMedivators Inc—
Similar devices
Select up to two to place side-by-side with this device.