Skip to content
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.

  • United StatesAHTO07613327061499
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.

3 linked reportsMalfunction 3
01112019-03: 1 reports for this device2020-03: 1 reports for this device2020-07: 1 reports for this device030307
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-031—
2020-031—
2020-071—
This device (reports/month)Average device in its product code (reports/device/month)
Failure-mode summaryAI-generated

3 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2020-07-2810331918MalfunctionAvailableexact di
2020-03-059792382MalfunctionAvailableexact di
2019-03-208435777MalfunctionAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

Similar devices
    Select up to two to place side-by-side with this device.