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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
    2023-11-02VAIVoluntary action indicatedGyrus ACMI, Inc.3
    2022-05-02NAINo action indicatedGyrus ACMI, Inc.0
    2020-01-14NAINo action indicatedGyrus ACMI, Inc.0
    2018-05-23NAINo action indicatedGyrus ACMI, Inc.0
    2018-04-17VAIVoluntary action indicatedGyrus ACMI, Inc.1
    2017-07-27NAINo action indicatedGyrus ACMI, Inc.0
    2016-08-17NAINo action indicatedGyrus ACMI, Inc.0
    2016-07-01NAINo action indicatedGyrus ACMI, Inc.0
    2015-12-11NAINo action indicatedGyrus ACMI, Inc.0
    2015-04-03VAIVoluntary action indicatedGyrus ACMI, Inc.1
    2015-03-20NAINo action indicatedGyrus ACMI, Inc.0
    2013-09-18VAIVoluntary action indicatedGyrus ACMI, Inc.4
    2013-06-21VAIVoluntary action indicatedGyrus ACMI, Inc.1
    2013-06-11VAIVoluntary action indicatedGyrus Acmi, Inc.2
    2012-08-31NAINo action indicatedGyrus ACMI, Inc.0
    2012-06-14VAIVoluntary action indicatedGyrus ACMI, Inc.2
    2011-06-13NAINo action indicatedGyrus ACMI, Inc.0
    2010-09-15NAINo action indicatedGyrus ACMI, Inc.0
    2010-06-24NAINo action indicatedGyrus Acmi, Inc.0
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