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Hydromark
No active recall
FDA product code: NEU · Category: Marker, Radiographic, Implantable
Severity Snapshot
35 total reports2014-12 – 2026-03 date range73.5% physician / facility reported26.5% manufacturer reported1 SKU variants
Reporting Trend
Annual Reporting Volume
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Note: the 2018 Voluntary Malfunction Summary Reporting expansion means volume increases may reflect surveillance changes, not increased device risk.
Reported Events
Submitted to FDA MAUDE by physicians, hospitals, manufacturers, and patients.
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