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FLOWTRON

ArjoHuntleigh AB

UDILibrary device dossier · generated 2026-09-11 · 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 (7)

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: 7

12232025-11: 3 reports for this device2025-12: 2 reports for this device2026-01: 2 reports for this device111201
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2025-113—
2025-122—
2026-012—
This device (reports/month)Average device in its product code (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — ArjoHuntleigh AB

  • NAI 2015-04-23 Arjo (Suzhou) Co., Ltd. · 0 citations
  • VAI 2014-03-20 ARJOHUNTLEIGH POLSKA Sp. z.o.o. · 3 citations
  • NAI 2013-02-07 ARJOHUNTLEIGH AB · 0 citations
  • NAI 2013-02-07 ARJOHUNTLEIGH AB · 0 citations
  • VAI 2012-09-06 Huntleigh Healthcare Ltd. · 0 citations
  • NAI 2011-11-24 Arjo (Suzhou) Co., Ltd. · 0 citations