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10731 Dual Tip Skin Marker; Regular and Fine Tip Gentian Violet

Model 10731 · XODUS MEDICAL, INC. · DI 00787551008517

FZZ — Marker, Skin · Class I · 21 CFR 878.4660

UDILibrary device dossier · generated 2026-09-06 · 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)
2019-11	0	1
2021-09	0	1
2023-08	0	1

This device (reports/month)Average device in FZZ (reports/device/month)

Regulatory clearances

None linked in the loaded window.

Manufacturer compliance record — XODUS MEDICAL, INC.

NAI 2026-02-06 Xodus Medical Inc · 0 citations
NAI 2026-02-06 Xodus Medical Inc · 0 citations
VAI 2019-08-14 Xodus Medical Inc · 7 citations
VAI 2019-08-14 Xodus Medical Inc · 7 citations
NAI 2017-10-10 Xodus Medical Inc · 0 citations
NAI 2017-10-10 Xodus Medical Inc · 0 citations
NAI 2015-07-10 Xodus Medical Inc · 0 citations
NAI 2015-07-10 Xodus Medical Inc · 0 citations
VAI 2013-02-19 Xodus Medical Inc · 2 citations
VAI 2013-02-19 Xodus Medical Inc · 2 citations
NAI 2012-09-21 Xodus Medical Inc · 0 citations
NAI 2012-09-21 Xodus Medical Inc · 0 citations
NAI 2010-09-13 Xodus Medical Inc · 0 citations
NAI 2010-09-13 Xodus Medical Inc · 0 citations