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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

    Cited as predicate by: K252067

    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
    2026-01-13VAIVoluntary action indicatedConformis Inc.1
    2023-03-09VAIVoluntary action indicatedConformis, Inc.4
    2021-07-08NAINo action indicatedConformis Inc.0
    2019-12-10WLWarning LetterConformis Inc.—
    2019-09-20VAIVoluntary action indicatedConformis, Inc.2
    2019-09-20OAIOfficial action indicatedConformis Inc.4
    2018-09-07VAIVoluntary action indicatedConformis, Inc.6
    2015-09-14VAIVoluntary action indicatedConformis Inc.3
    2015-06-12NAINo action indicatedConformis, Inc.0
    2013-03-18NAINo action indicatedConformis, Inc.0
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