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AMMA
COOLER HEADS CARE, INC. · Model Accessory Kit, Small, 1-pack · UDI-DI 00850051245017
PMC
Prescription
1
510(k) clearances
58
Adverse events (1 deaths)
1
Recalls
7
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-11-05 | Dignitana, Inc. | Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated |
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