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 StatesFlyte04546540591579
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 device2020-10: 1 reports for this device2021-01: 1 reports for this device2022-07: 1 reports for this device07100107
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-071—
2020-101—
2021-011—
2022-071—
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
2022-07-263015967359-2022-01369MalfunctionAvailableexact di
2021-01-220001811755-2021-00168MalfunctionAvailableexact di
2020-10-280001811755-2020-02867MalfunctionAvailableexact di
2019-07-230001811755-2019-02383MalfunctionAvailableexact 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.