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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 StatesiBur07613327498851
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
01112022-06: 1 reports for this device2023-04: 1 reports for this device2026-04: 1 reports for this device060404
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-061—
2023-041—
2026-041—
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
2026-04-223015967359-2026-99275MalfunctionAvailableexact di
2023-04-193015967359-2023-00767MalfunctionAvailableexact di
2022-06-170001811755-2022-00024MalfunctionAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2011-01-05NAINo action indicatedStryker Instruments0
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