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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

    K093430

    Cited as predicate by: K103419, K111379, K113309, K121220, K131298, K162567

    Cited as predicate by: K162567, K212356

    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
    2025-12-19WLWarning LetterExactech Sarasota, Inc.—
    2025-08-27OAIOfficial action indicatedExactech, Inc.9
    2025-08-27OAIOfficial action indicatedExactech, Inc.9
    2025-07-25OAIOfficial action indicatedExactech Sarasota, Inc.7
    2024-10-09VAIVoluntary action indicatedExactech, Inc.0
    2024-10-09VAIVoluntary action indicatedExactech, Inc.0
    2024-01-19WLWarning LetterExactech, Inc.—
    2024-01-19WLWarning LetterExactech, Inc.—
    2023-09-26OAIOfficial action indicatedExactech, Inc.2
    2023-09-26OAIOfficial action indicatedExactech, Inc.2
    2021-11-17VAIVoluntary action indicatedExactech, Inc.4
    2021-11-17VAIVoluntary action indicatedExactech, Inc.4
    2020-01-31VAIVoluntary action indicatedExactech, Inc.7
    2020-01-31VAIVoluntary action indicatedExactech, Inc.7
    2017-03-10VAIVoluntary action indicatedExactech, Inc.7
    2017-03-10VAIVoluntary action indicatedExactech, Inc.7
    2015-07-16NAINo action indicatedExactech, Inc.0
    2015-07-16NAINo action indicatedExactech, Inc.0
    2014-08-25NAINo action indicatedExactech Sarasota, Inc.0
    2012-12-11NAINo action indicatedExactech, Inc.0
    2012-12-11NAINo action indicatedExactech, Inc.0
    2010-03-25VAIVoluntary action indicatedExactech, Inc.0
    2010-03-25VAIVoluntary action indicatedExactech, Inc.0
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