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IRIS-XP
Medicore Co., Ltd. · Model IRIS · UDI-DI 00191237000069
LHQ
Prescription
1
510(k) clearances
6
Adverse events (1 deaths)
1
Recalls
13
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-01-14 | Med-Hot Thermal Imaging, Inc. | Indications for use are not cleared or approved for market in the U.S. |
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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.