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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 StatesiBur07613327501278
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.

4 linked reportsMalfunction 4
11222023-02: 2 reports for this device2023-03: 1 reports for this device2025-04: 1 reports for this device020304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2023-022—
2023-031—
2025-041—
This device (reports/month)Average device in its product code (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-04-303015967359-2025-00967MalfunctionAvailableexact di
2023-03-313015967359-2023-00652MalfunctionAvailableexact di
2023-02-163015967359-2023-00433MalfunctionAvailableexact di
2023-02-153015967359-2023-00428MalfunctionAvailableexact di
Regulatory clearances

None linked.

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