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WROOTBOL NOTIPATCH

ONE POWER · Model DR-TZ+365 · UDI-DI 08800105200150

FQZ
10
510(k) clearances
6
Adverse events
2
Recalls
46
Facilities

Description

Thermometer, colour-indicating

Recalls

DateFirmReason
2023-05-10BearCare, Inc.There have been reports of skin burns to children wearing the device.
2013-07-10Medical Indicators, Inc.TempaDot products may have been mislabeled.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.