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Infrascanner

INFRASCAN, INC. · Model 2000 · UDI-DI 00861606000302

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510(k) clearances
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Adverse events
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Recalls
2
Facilities

Description

Handheld Brain Hematoma Detector

Recalls

DateFirmReason
2013-10-16Cutera, Inc.Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate un

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.