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Flyte, SurgiCool

Stryker Instruments

UDILibrary device dossier · generated 2026-09-06 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (3)

Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 3

01112024-10: 1 reports for this device2025-01: 1 reports for this device2025-07: 1 reports for this device100107
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2024-101—
2025-011—
2025-071—
This device (reports/month)Average device in its product code (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Stryker Instruments

  • NAI 2011-01-05 Stryker Instruments · 0 citations