Home › Device types › PMC
Scalp Cooling System
FDA product code PMC · Class 2 · General, Plastic Surgery
63
Registered devices
57
Adverse events
1
Recalls
7
510(k) clearances
Devices with this code
DigniCap® Delta — Dignitana ABDigniCap® Delta — Dignitana ABDigniCap — Dignitana ABPSCS — PAXMAN COOLERS LIMITEDAMMA — Cooler Heads Care, Inc.DigniCap — Dignitana ABPSCS Coolant — PAXMAN COOLERS LIMITEDPaxman cap kit — PAXMAN COOLERS LIMITEDDigniCap® Delta — Dignitana ABPaxman Cooling Cap — PAXMAN COOLERS LIMITEDDigniCap® Delta — Dignitana ABDigniCap® Delta — Dignitana ABPaxman cap kit — PAXMAN COOLERS LIMITEDDigniCool — Dignitana ABPaxman Cooling cap — PAXMAN COOLERS LIMITEDDigniCap® Delta — Dignitana ABAMMA — Cooler Heads Care, Inc.DigniCap® Delta — Dignitana ABDigniCap® Delta — Dignitana ABAMMA — Cooler Heads Care, Inc.DigniCap® Delta — Dignitana ABPaxman Cooling Cap — PAXMAN COOLERS LIMITEDDigniCap® Delta — Dignitana ABAMMA — 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.