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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.

  • United StatesAHTO07613327061659
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.

5 linked reportsMalfunction 5
11222019-06: 1 reports for this device2019-09: 2 reports for this device2021-05: 1 reports for this device2025-10: 1 reports for this device06090510
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-061—
2019-092—
2021-051—
2025-101—
This device (reports/month)Average device in its product code (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-10-3023424940MalfunctionAvailableexact di
2021-05-1811841002MalfunctionAvailableexact di
2019-09-170002936485-2019-00400MalfunctionAvailableexact di
2019-09-129005710MalfunctionAvailableexact di
2019-06-148699619MalfunctionAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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