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Dermal Cooling System
R2 Technologies, Inc. · Model HP-002 · UDI-DI 00850019947045
1
510(k) clearances
24
Adverse events (2 deaths)
7
Recalls
19
Facilities
Description
The Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures. benign lesions of the skin.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-09-03 | Gebauer Company | Some units of Fluro-Ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the n |
| 2007-04-17 | Gebauer Company | Mold contamination |
| 2007-04-17 | Gebauer Company | Mold contamination |
| 2007-04-17 | Gebauer Company | Mold contamination |
| 2007-04-17 | Gebauer Company | Mold contamination |
| 2007-04-17 | Gebauer Company | Mold contamination |
| 2007-04-17 | Gebauer Company | Mold contamination |
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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.