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ABL80 CO-OX Capillary adapter

Radiometer Medical ApS

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 (0)

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.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Radiometer Medical ApS

  • NAI 2025-12-04 SenDx Medical, Inc. · 0 citations
  • NAI 2024-09-19 Radiometer Medical ApS · 0 citations
  • NAI 2024-09-19 Radiometer Medical ApS · 0 citations
  • NAI 2017-05-17 Radiometer Sp z.o.o. · 0 citations
  • NAI 2017-05-11 Radiometer Medical ApS · 0 citations
  • NAI 2017-05-11 Radiometer Medical ApS · 0 citations
  • VAI 2016-10-20 Radiometer Basel AG · 2 citations
  • VAI 2015-03-02 Radiometer America Inc · 4 citations
  • VAI 2011-08-18 Radiometer America Inc · 3 citations