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Model EOS Extraoral Suction System · Guangzhou Ajax Medical Equipment Co., Ltd. · DI 06971608312557

FRA — Purifier, Air, Ultraviolet, Medical · Class II · 21 CFR 880.6500

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.

11222021-05: 0 reports for this device; peer average 2/device05
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0502
This device (reports/month)Average device in FRA (reports/device/month)

Regulatory clearances

  • K202766 SESE 2021-06-11 (k number procode)

Predicate lineage

K202766 — cites (transitively): K200500 (d1), K052732 (d2), K161468 (d2)

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Guangzhou Ajax Medical Equipment Co., Ltd.

Nothing in the loaded window.