Product code MLY · Class U
Vapocoolant Device
2510(k)s in 12 months (25 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in MLY
| Company | 510(k)s | Recalls |
|---|---|---|
| Gebauer Co. | 10 | 7 |
| Nuance Medical, LLC | 3 | 0 |
| Vapocoolshot, Inc. | 3 | 0 |
| 623 Medical, LLC | 1 | 0 |
| Ari | 1 | 0 |
| Cryonic Medical North America | 1 | 0 |
| Cryoscience North America, Inc. | 1 | 0 |
| Cryosurgery, Inc. | 1 | 0 |
| Dukal Corp. | 1 | 0 |
| Itw Contamination Control Electronics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 5, 2026 | K261684 | FreezeSpray TA Cryosurgery, Inc. | MLY |
| Aug 27, 2026 | K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) Gebauer Company | MLY |
| May 30, 2025 | K243654 | DentalJect Vapocoolshot, Inc. | MLY |
| Feb 12, 2024 | K232674 | PainFreeze II Nuance Medical, LLC | MLY |
| May 25, 2022 | K203661 | CRYO Arctic, CRYO Penguin Cryoscience North America, Inc. | MLY |
| Dec 21, 2020 | K202782 | num Vapocoolant 623 Medical, LLC | MLY |
| Aug 12, 2020 | K201248 | Syringe Holder accessory Vapocoolshot, Inc. | MLY |
| Apr 14, 2020 | K193349 | Vapocoolshot Mist Vapocoolshot, Inc. | MLY |
| May 7, 2019 | K190161 | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360 Gebauer Company | MLY |
| Apr 19, 2018 | K172598 | Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE Itw Contamination Control Electronics | MLY |
| Oct 27, 2017 | K172028 | Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) Gebauer Company | MLY |
| Oct 18, 2017 | K172203 | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray Nuance Medical, LLC | MLY |
| Nov 22, 2016 | K162218 | Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102 Nuance Medical, LLC | MLY |
| Jun 15, 2010 | K093951 | OUCHLESS MODEL PN10114 Occam Design | MLY |
| Jun 10, 2005 | K033720 | ARI COLD SPRAY Ari | MLY |
| Mar 17, 2004 | K032671 | GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 Gebauer Co. | MLY |
| Aug 20, 2003 | K030281 | CRYOTRON 2 CRYOTHERAPY DEVICE Cryonic Medical North America | MLY |
| Jul 10, 2003 | K031036 | GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM SPRAY), MODEL P/N-03 Gebauer Co. | MLY |
| Dec 12, 2002 | K021726 | GEBAUER'S INSTANT ICE Gebauer Co. | MLY |
| Feb 15, 2001 | K002596 | GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 Gebauer Co. | MLY |
| Jan 25, 2001 | K001624 | GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 Gebauer Co. | MLY |
| Jan 21, 2000 | K992286 | DERMAFREEZE Rhealm Pharmaceuticals, Inc. | MLY |
| Dec 2, 1999 | K984564 | ETHYL CHLORIDE DISPENSER Dukal Corp. | MLY |
| Jul 16, 1999 | K991514 | GEBAUER'S CHLORIDE FINE NOZZE Gebauer Co. | MLY |
| Sep 29, 1994 | K930915 | FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE Gebauer Co. | MLY |
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