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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

    K071951

    Cited as predicate by: K112288, K161349

    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
    2024-11-22VAIVoluntary action indicatedAxiobionics, LLC3
    2024-11-22VAIVoluntary action indicatedAxiobionics, LLC3
    2016-02-18VAIVoluntary action indicatedAxiobionics, LLC3
    2016-02-18VAIVoluntary action indicatedAxiobionics, LLC3
    2014-05-15VAIVoluntary action indicatedAxiobionics, LLC3
    2014-05-15VAIVoluntary action indicatedAxiobionics, LLC3
    2012-12-07WLWarning LetterAxiobionics, LLC—
    2012-12-07WLWarning LetterAxiobionics, LLC—
    2012-07-25OAIOfficial action indicatedAxiobionics, LLC8
    2012-07-25OAIOfficial action indicatedAxiobionics, LLC8
    2011-06-29OAIOfficial action indicatedAxiobionics, LLC9
    2011-06-29OAIOfficial action indicatedAxiobionics, LLC9
    2010-02-08NAINo action indicatedAxiobionics, LLC0
    2010-02-08NAINo action indicatedAxiobionics, LLC0
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