Home › Device types › MLY
Vapocoolant Device
FDA product code MLY · Class U · Unknown
55
Registered devices
24
Adverse events
7
Recalls
23
510(k) clearances
Devices with this code
Gebauer's Ethyl Chloride Fine Spray Accu-Stream 360 — GEBAUER COMPANYCryoDose TA — NUANCE MEDICAL, LLCCoolject 1-3cc Syringe Holder Nozzle Accessory — Vapocoolshot, IncCoolJect Targeted-Mist Topical Anesthetic — Vapocoolshot, IncInstaNumb — BEUTLICH PHARMACEUTICALS, LLCTargetCool — RecensMedical, Inc.Hurri-Freeze — BEUTLICH PHARMACEUTICALS, LLCMcKesson — MCKESSON MEDICAL-SURGICAL INC.NUM Vapocoolant — Gilero, LLCCoolJect Targeted-Mist Topical Anesthetic — Vapocoolshot, IncMcKesson — MCKESSON MEDICAL-SURGICAL INC.Coolject 1-3cc Syringe Holder Nozzle Accessory — Vapocoolshot, IncCryoDose TA — NUANCE MEDICAL, LLCGebauer's Spray and Stretch — GEBAUER COMPANYDentalJect Syringe Connector — Vapocoolshot, IncCoolject Topical Anesthetic Canister — Vapocoolshot, IncGebauer's Pain Ease Mist Spray — GEBAUER COMPANYCoolJect Targeted-Mist Topical Anesthetic — Vapocoolshot, IncHexa — Hexa DentalGebauer's Instant Ice — GEBAUER COMPANYHurri-Freeze — BEUTLICH PHARMACEUTICALS, LLCCoolject Standard Nozzle Accessory — Vapocoolshot, IncDentalJect Starter Kit — Vapocoolshot, IncCoolject Topical Anesthetic Canister — Vapocoolshot, Inc
Recent 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 |
| 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 |
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.