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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

    K112452

    Cited as predicate by: K151724, K161596

    Cited as predicate by: K173762, K180054, K180286, K181722

    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
    2025-01-10VAIVoluntary action indicatedAngiodynamics, Inc.2
    2025-01-10VAIVoluntary action indicatedAngiodynamics, Inc.2
    2021-06-25VAIVoluntary action indicatedAngioDynamics, Inc.2
    2021-06-25VAIVoluntary action indicatedAngioDynamics, Inc.2
    2016-04-21VAIVoluntary action indicatedAngiodynamics, Inc.6
    2016-04-21VAIVoluntary action indicatedAngiodynamics, Inc.6
    2016-04-15VAIVoluntary action indicatedAngioDynamics, Inc.3
    2016-04-15VAIVoluntary action indicatedAngioDynamics, Inc.3
    2015-08-24VAIVoluntary action indicatedAngiodynamics Inc1
    2015-08-24VAIVoluntary action indicatedAngiodynamics Inc1
    2015-08-24VAIVoluntary action indicatedAngiodynamics Inc1
    2015-08-24VAIVoluntary action indicatedAngiodynamics Inc1
    2015-08-13VAIVoluntary action indicatedAngioDynamics, Inc.0
    2015-08-13VAIVoluntary action indicatedAngioDynamics, Inc.0
    2014-11-04WLWarning LetterAngioDynamics, Inc.—
    2014-11-04WLWarning LetterAngioDynamics, Inc.—
    2014-07-15VAIVoluntary action indicatedAngioDynamics, Inc.3
    2014-07-15VAIVoluntary action indicatedAngioDynamics, Inc.3
    2014-05-28OAIOfficial action indicatedAngiodynamics Inc7
    2014-05-28OAIOfficial action indicatedAngiodynamics Inc7
    2014-03-30OAIOfficial action indicatedAngioDynamics, Inc.0
    2014-03-30OAIOfficial action indicatedAngioDynamics, Inc.0
    2011-05-27WLWarning LetterAngiodynamics, Inc.—
    2011-05-27WLWarning LetterAngiodynamics, Inc.—
    2011-01-21WLWarning LetterAngiodynamics, Inc.—
    2011-01-21WLWarning LetterAngiodynamics, Inc.—
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