Print-ready dossier — use your browser's print dialog to save as PDF.
AMSCO
Model Drying Cabinet · Corporation Steris Canada · DI 00724995162672
PUP — Endoscope Maintenance System · Class II · 21 CFR 876.1500
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2023-07
0
1
2024-01
0
1
2024-02
0
1.5
2024-08
0
1.25
2024-09
0
2.5
2024-12
0
1.13
2025-01
0
2
2025-07
0
1.25
2025-10
0
1.5
2025-12
0
2.8
2026-01
0
1.5
2026-03
0
1.5
2026-04
0
1.5
2026-05
0
1.6
This device (reports/month)Average device in PUP (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Corporation Steris Canada