Product code MLY ยท 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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2008 | Gebauer Company Gebauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator.
Gebauer's Fluro-Ethyl is a vapocoolan Terminated |
MLY | K002596 |
| Jul 23, 2007 | Gebauer Company Gebauer''s Pain Ease Sample Spray -Topical Anesthtic Skin Refrigerant is a vapocoolant (skin refrigerant) packed in an aerosol container, Rx only, 30 mL(1.0 fl. oz.) can.-(Product Number-0386-0008-01) Terminated |
MLY | K032671 |
| Jul 23, 2007 | Gebauer Company Gebauer''s Pain Ease Medium Stream -Topical Anesthetic Skin Refrigerant is a vapocoolant (skin refrigerant) packed in an aerosol container. Rx only. 103.5ml (3.5 fl. oz.) can-(Product Number-0386-0 Terminated |
MLY | K032671 |
| Jul 23, 2007 | Gebauer Company Gebauer''s Instant Ice Medium Stream - temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries.-3.5 fl. oz. (103.5ml) can-(Produc Terminated |
MLY | K021726 |
| Jul 23, 2007 | Gebauer Company Gebauer''s Instant Ice Mist- is used like ice for the temporary relief and reduction of minor pain and swelling from sprains, strains, bruising, contusions or minor sports injuries. 3.5 fl. oz. (103. Terminated |
MLY | K021726 |
| Jul 23, 2007 | Gebauer Company Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is intended for topical application to skin for use in controlling pain associated with injections and the temporary reli Terminated |
MLY | K031036 |
| Jul 23, 2007 | Gebauer Company Gebauer''s Pain Ease Mist Spray- Topical Anesthetic Skin Refrigerant -is a vapocoolant (skin refrigerant) packed in an aerosol container. Rx only-103.5ml (3.5 fl. oz.) can. Product Number 0386-0008-02 Terminated |
MLY | K032671 |
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