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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)K181292Substantially equivalent (SESE) · 2018-11-15clearance 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
2022-04-14VAIVoluntary action indicatedCogentix Medical, Inc.1
2022-04-14VAIVoluntary action indicatedCogentix Medical, Inc.1
2020-02-28NAINo action indicatedCogentix Medical LLC0
2020-02-28NAINo action indicatedCogentix Medical LLC0
2017-08-31NAINo action indicatedCogentix Medical LLC0
2017-08-31NAINo action indicatedCogentix Medical LLC0
2014-08-08VAIVoluntary action indicatedCogentix Medical, Inc.2
2014-08-08VAIVoluntary action indicatedCogentix Medical, Inc.2
2013-05-01VAIVoluntary action indicatedCogentix Medical, Inc.2
2013-05-01VAIVoluntary action indicatedCogentix Medical, Inc.2
2012-06-01NAINo action indicatedCogentix Medical LLC0
2012-06-01NAINo action indicatedCogentix Medical LLC0
2011-02-11VAIVoluntary action indicatedCogentix Medical, Inc.4
2011-02-11VAIVoluntary action indicatedCogentix Medical, Inc.4
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