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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

    K941541

    Cited as predicate by: K200216, K201198, K223759

    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
    2026-05-13NAINo action indicatedBiorez, Inc0
    2026-04-06VAIVoluntary action indicatedConMed Corporation6
    2026-04-06VAIVoluntary action indicatedConMed Corporation6
    2023-12-14NAINo action indicatedLinvatec Corp.0
    2023-08-04VAIVoluntary action indicatedBiorez, Inc1
    2022-11-10NAINo action indicatedConMed Corporation0
    2022-11-10NAINo action indicatedConMed Corporation0
    2022-07-13NAINo action indicatedConMed Corporation0
    2022-07-13NAINo action indicatedConMed Corporation0
    2020-09-22VAIVoluntary action indicatedConMed Corporation0
    2020-09-22VAIVoluntary action indicatedConMed Corporation0
    2019-10-17NAINo action indicatedConMed Corporation0
    2019-10-17NAINo action indicatedConMed Corporation0
    2017-02-03VAIVoluntary action indicatedConMed Corporation2
    2017-02-03VAIVoluntary action indicatedConMed Corporation2
    2017-01-23NAINo action indicatedConmed0
    2016-02-03VAIVoluntary action indicatedConMed Corporation5
    2016-02-03VAIVoluntary action indicatedConMed Corporation5
    2014-11-18NAINo action indicatedConMed Corporation0
    2014-11-18NAINo action indicatedConMed Corporation0
    2014-01-29WLWarning LetterConMed Corporation—
    2014-01-29WLWarning LetterConMed Corporation—
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