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Bioteque

Model OS265BA-2 · Bioteque Taiwan Ltd. · DI 04719894432441

HDQ — Dilator, Cervical, Fixed Size · Class I · 21 CFR 884.4530

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 — Bioteque Taiwan Ltd.

  • NAI 2020-01-23 Bioteque Taiwan Ltd. · 0 citations
  • NAI 2020-01-23 Bioteque Taiwan Ltd. · 0 citations
  • VAI 2016-12-08 Bioteque Taiwan Ltd. · 1 citations
  • VAI 2016-12-08 Bioteque Taiwan Ltd. · 1 citations
  • NAI 2014-04-03 Bioteque Taiwan Ltd. · 0 citations
  • NAI 2014-04-03 Bioteque Taiwan Ltd. · 0 citations