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

AMD-RITMED

Model E8010 · AMD Medicom Inc · DI 10686864053689

OEA — Non-Surgical Gown · Class I · 21 CFR 878.4040

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.

11222019-04: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 2/device2024-08: 0 reports for this device; peer average 1/device0403090701030708
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0401
2020-0301
2020-0902
2021-0702
2024-0102
2024-0302
2024-0702
2024-0801
This device (reports/month)Average device in OEA (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — AMD Medicom Inc

  • VAI 2012-12-13 AMD Medicom Inc. · 5 citations
  • NAI 2010-02-01 AMD Medicom Inc. · 0 citations