Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

AADCO

Model OSP-60PC · AADCO MEDICAL, INC. · DI 00840348504231

IWX — Barrier, Control Panel, X-Ray, Movable · Class I · 21 CFR 892.6500

UDILibrary device dossier · generated 2026-09-16 · 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 — AADCO MEDICAL, INC.

  • VAI 2023-02-22 AADCO Medical Inc. · 5 citations
  • VAI 2023-02-22 AADCO Medical Inc. · 5 citations
  • NAI 2014-08-13 AADCO Medical Inc. · 0 citations
  • NAI 2014-08-13 AADCO Medical Inc. · 0 citations
  • NAI 2012-06-26 AADCO Medical Inc. · 0 citations
  • NAI 2012-06-26 AADCO Medical Inc. · 0 citations