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Wilson-Cook Medical, Inc.

UDILibrary device dossier · generated 2026-09-10 · 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 (1)

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: 1

01112026-03: 1 reports for this device03
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2026-031—
This device (reports/month)Average device in its product code (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Wilson-Cook Medical, Inc.

  • Warning Letter 2011-06-24 Wilson-Cook Medical Inc.
  • NAI 2025-10-24 Wilson-Cook Medical Inc. · 0 citations
  • VAI 2014-12-23 Wilson-Cook Medical Inc. · 2 citations
  • VAI 2012-03-06 Wilson-Cook Medical Inc. · 6 citations
  • OAI 2011-04-19 Wilson-Cook Medical Inc. · 8 citations