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Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

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

    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
    2018-09-13NAINo action indicatedSOMNOmedics AG0
    2018-09-13NAINo action indicatedSOMNOmedics AG0
    2015-05-07VAIVoluntary action indicatedSOMNOmedics AG3
    2015-05-07VAIVoluntary action indicatedSOMNOmedics AG3
    2012-07-12VAIVoluntary action indicatedSOMNOmedics AG1
    2012-07-12VAIVoluntary action indicatedSOMNOmedics AG1
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