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TempaDOT
MEDICAL INDICATORS INC · Model 5532 · UDI-DI 00016944301080
10
510(k) clearances
6
Adverse events
2
Recalls
46
Facilities
Description
TempaDOT C Sterile Single use Clinical Thermometer
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-10 | BearCare, Inc. | There have been reports of skin burns to children wearing the device. |
| 2013-07-10 | Medical Indicators, Inc. | TempaDot products may have been mislabeled. |
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Get your free API keyRead the docsData 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.