Panels › General, Plastic Surgery › Product code PMC · Class 2
Scalp Cooling System
Regulation 878.4360
1510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PMC
| Company | 510(k)s | Recalls |
|---|---|---|
| Dignitana AB | 3 | 1 |
| Paxman Coolers Limited | 2 | 0 |
| Cooler Heads Care, Inc. | 1 | 0 |
| Stemtech Medical Devices Private Limited | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 25, 2025 | K252289 | Eva Scalp Cooling System Stemtech Medical Devices Private Limited, IN | PMC |
| Oct 21, 2021 | K211526 | Portable Scalp Cooling System Cooler Heads Care, Inc. | PMC |
| Jun 26, 2019 | K191166 | DigniCap Delta Dignitana, Inc. | PMC |
| Jun 7, 2018 | K173032 | Paxman Scalp Cooler Paxman Coolers Limited, GB | PMC |
| Jul 3, 2017 | K170871 | DigniCap Scalp Cooling System Dignitana AB, SE | PMC |
| Apr 17, 2017 | K163484 | Paxman Scalp Cooler Paxman Coolers Limited, GB | PMC |
| Dec 8, 2015 | DEN150010 | Dignitana AB DigniCap System Dignitana AB, SE | PMC |
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