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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

    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
    2023-12-15VAIVoluntary action indicatedAvanos Medical, Inc.3
    2023-12-15VAIVoluntary action indicatedAvanos Medical, Inc.3
    2018-10-02VAIVoluntary action indicatedAvanos Medical, Inc.1
    2018-10-02VAIVoluntary action indicatedAvanos Medical, Inc.1
    2016-07-29VAIVoluntary action indicatedAvanos Medical, Inc.1
    2016-07-29VAIVoluntary action indicatedAvanos Medical, Inc.1
    2014-11-05NAINo action indicatedAvanos Medical, Inc.0
    2014-11-05NAINo action indicatedAvanos Medical, Inc.0
    2014-03-07VAIVoluntary action indicatedAvanos Medical, Inc.4
    2014-03-07VAIVoluntary action indicatedAvanos Medical, Inc.4
    2013-12-10NAINo action indicatedAvanos Medical, Inc.0
    2013-12-10NAINo action indicatedAvanos Medical, Inc.0
    2013-04-10WLWarning LetterAvanos Medical, Inc.—
    2013-04-10WLWarning LetterAvanos Medical, Inc.—
    2013-01-04OAIOfficial action indicatedAvanos Medical, Inc.6
    2013-01-04OAIOfficial action indicatedAvanos Medical, Inc.6
    2012-10-31OAIOfficial action indicatedAvanos Medical, Inc.10
    2012-10-31OAIOfficial action indicatedAvanos Medical, Inc.10
    2011-07-08VAIVoluntary action indicatedAvanos Medical, Inc.8
    2011-07-08VAIVoluntary action indicatedAvanos Medical, Inc.8
    2010-11-19OAIOfficial action indicatedAvanos Medical, Inc.4
    2010-11-19OAIOfficial action indicatedAvanos Medical, Inc.4
    2008-12-22WLWarning LetterAvanos Medical, Inc.—
    2008-12-22WLWarning LetterAvanos Medical, Inc.—
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