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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)K260903Substantially equivalent (SESE) · 2026-04-16clearance 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
2026-02-06NAINo action indicatedXodus Medical Inc0
2026-02-06NAINo action indicatedXodus Medical Inc0
2019-08-14VAIVoluntary action indicatedXodus Medical Inc7
2019-08-14VAIVoluntary action indicatedXodus Medical Inc7
2017-10-10NAINo action indicatedXodus Medical Inc0
2017-10-10NAINo action indicatedXodus Medical Inc0
2015-07-10NAINo action indicatedXodus Medical Inc0
2015-07-10NAINo action indicatedXodus Medical Inc0
2013-02-19VAIVoluntary action indicatedXodus Medical Inc2
2013-02-19VAIVoluntary action indicatedXodus Medical Inc2
2012-09-21NAINo action indicatedXodus Medical Inc0
2012-09-21NAINo action indicatedXodus Medical Inc0
2010-09-13NAINo action indicatedXodus Medical Inc0
2010-09-13NAINo action indicatedXodus Medical Inc0
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