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 StatesFlyte04546540591609
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
01112019-07: 1 reports for this device2021-04: 1 reports for this device2022-01: 1 reports for this device2022-04: 1 reports for this device07040104
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-071—
2021-041—
2022-011—
2022-041—
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
2022-04-253015967359-2022-00744MalfunctionAvailableexact di
2022-01-193015967359-2022-00085MalfunctionAvailableexact di
2021-04-263015967359-2021-00547MalfunctionAvailableexact di
2019-07-230001811755-2019-02384MalfunctionAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2011-01-05NAINo action indicatedStryker Instruments0
Similar devices
    Select up to two to place side-by-side with this device.