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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

    K091114

    Cited as predicate by: K120290, K121434

    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
    2016-09-16NAINo action indicatedQuality Electrodynamics LLC0
    2016-09-16NAINo action indicatedQuality Electrodynamics LLC0
    2015-04-10WLWarning LetterQuality Electrodynamics LLC—
    2015-04-10WLWarning LetterQuality Electrodynamics LLC—
    2015-03-09OAIOfficial action indicatedQuality Electrodynamics LLC9
    2015-03-09OAIOfficial action indicatedQuality Electrodynamics LLC9
    2011-07-27NAINo action indicatedQuality Electrodynamics LLC0
    2011-07-27NAINo action indicatedQuality Electrodynamics LLC0
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