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Scalp Cooling System
FDA product code PMC · Class 2 · General, Plastic Surgery
67
Registered devices
58
Adverse events
1
Recalls
7
510(k) clearances
Devices with this code
Paxman Cooling cap — PAXMAN COOLERS LIMITEDAMMA — COOLER HEADS CARE, INC.DigniCap® Delta — Dignitana ABAMMA — COOLER HEADS CARE, INC.Cooler Heads — PATHWAY, LLCPaxman cap kit — PAXMAN COOLERS LIMITEDDigniCap® Delta — Dignitana ABDigniCool — Dignitana ABDigniCap® Delta — Dignitana ABDigniCap — Dignitana ABDigniCap® Delta — Dignitana ABDigniCap® Delta — Dignitana ABDigniCap — Dignitana ABDigniCap® Delta — Dignitana ABPaxman Cooling Cap — PAXMAN COOLERS LIMITEDPSCS — PAXMAN COOLERS LIMITEDPaxman Cooling Cap — PAXMAN COOLERS LIMITEDPaxman Cooling Cap — PAXMAN COOLERS LIMITEDAMMA — COOLER HEADS CARE, INC.Paxman cap kit — PAXMAN COOLERS LIMITEDDigniCap — Dignitana ABAMMA — COOLER HEADS CARE, INC.AMMA — COOLER HEADS CARE, INC.AMMA — COOLER HEADS CARE, INC.
Recent 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. Addit |
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