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Adscope®

Model 658MG · AMERICAN DIAGNOSTIC CORP · DI 00634782083335

DQD — Stethoscope, Electronic · Class II · 21 CFR 870.1875

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.

23562024-11: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 6/device2025-12: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 1/device1108101205
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2024-1101
2025-0801
2025-1006
2025-1202
2026-0501
This device (reports/month)Average device in DQD (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — AMERICAN DIAGNOSTIC CORP

  • NAI 2014-07-30 American Diagnostic Corporation · 0 citations
  • NAI 2014-07-30 American Diagnostic Corporation · 0 citations
  • NAI 2010-12-07 American Diagnostic Corporation · 0 citations
  • NAI 2010-12-07 American Diagnostic Corporation · 0 citations