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"Super-Slide 1"" Wide Titanium Blade"
Model 7329-325 · KOROS U.S.A., INC. · DI 10840199500953
GZT — Retractor, Self-Retaining, For Neurosurgery · Class II · 21 CFR 882.4800
UDILibrary device dossier · generated 2026-09-12 · 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)
2020-01
0
3
2020-04
0
3
2021-02
0
3
2021-11
0
1
2022-04
0
1
2023-11
0
1
2023-12
0
1
2024-04
0
2
2024-09
0
1
2024-10
0
3
2024-11
0
1
2025-01
0
1
2025-08
0
1
2026-02
0
2
2026-03
0
1
2026-06
0
2
This device (reports/month)Average device in GZT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — KOROS U.S.A., INC.