Print-ready dossier — use your browser's print dialog to save as PDF.
1101 - SP Tray with adapters
Model 1101 · Ultra Clean Systems, Inc. · DI 00816634020273
FLG — Cleaner, Ultrasonic, Medical Instrument · Class I · 21 CFR 880.6150
UDILibrary device dossier · generated 2026-09-07 · 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)
2022-07
0
3
2023-03
0
3
2023-10
0
3
2023-11
0
2
2024-04
0
1
2024-05
0
1
2024-08
0
2
2024-09
0
3
2024-11
0
3
2025-01
0
4.5
2025-03
0
1
2025-05
0
3
2025-09
0
3
2025-12
0
1.5
2026-03
0
3
2026-05
0
1.67
2026-06
0
1
This device (reports/month)Average device in FLG (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Ultra Clean Systems, Inc.
VAI 2023-08-11 Ultra Clean Systems, Inc. · 6 citations