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)K091940Substantially equivalent (SESE) · 2010-03-26clearance family

Predicate lineage

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-03-27VAIVoluntary action indicatedTonica Elektronik A/S2
2025-03-27VAIVoluntary action indicatedTonica Elektronik A/S2
2015-03-19NAINo action indicatedTonica Elektronik A/S0
2015-03-19NAINo action indicatedTonica Elektronik A/S0
2012-11-06WLWarning LetterTonica Elektronik A/S—
2012-11-06WLWarning LetterTonica Elektronik A/S—
2012-08-02OAIOfficial action indicatedTonica Elektronik A/S3
2012-08-02OAIOfficial action indicatedTonica Elektronik A/S3
Similar devices
Select up to two to place side-by-side with this device.