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)K181948Substantially equivalent (SESE) · 2018-11-16clearance family
Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2018-07-05VAIVoluntary action indicatedRapid Biomedical GmbH4
2018-07-05VAIVoluntary action indicatedRapid Biomedical GmbH4
2012-06-28VAIVoluntary action indicatedRapid Biomedical GmbH2
2012-06-28VAIVoluntary action indicatedRapid Biomedical GmbH2
Similar devices
Select up to two to place side-by-side with this device.