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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: K181688, K183074

    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
    2016-12-07VAIVoluntary action indicatedGF Health Products, Inc.2
    2016-12-07VAIVoluntary action indicatedGF Health Products, Inc.2
    2016-03-25NAINo action indicatedGf Health Products0
    2016-03-25NAINo action indicatedGf Health Products0
    2012-06-12VAIVoluntary action indicatedGF Health Products, Inc2
    2012-06-12VAIVoluntary action indicatedGF Health Products, Inc2
    2012-03-07NAINo action indicatedGf Health Products0
    2012-03-07NAINo action indicatedGf Health Products0
    2011-12-08WLWarning LetterGF Health Products, Inc—
    2011-12-08WLWarning LetterGF Health Products, Inc—
    2011-09-23OAIOfficial action indicatedGF Health Products, Inc11
    2011-09-23OAIOfficial action indicatedGF Health Products, Inc11
    2010-06-03VAIVoluntary action indicatedGf Health Products0
    2010-06-03VAIVoluntary action indicatedGf Health Products0
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