Company · US
Gebauer Company
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2026. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (1 in 12 months)
9recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 27, 2026 | K260870 | Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) Gebauer Company | 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 |
| Oct 27, 2017 | K172028 | Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) Gebauer Company | 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 |
| 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 |
| Aug 6, 2001 | K981693 | SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 Gebauer Co. | LFD |
| 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 |
| 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 |
Latest recalls
| 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 |
| Mar 20, 2007 | Gebauer Company Salivart Oral Moisturizer, packaged in 2.5 fluid ounce (73.9 mL) spray cans, Part Number: 0386-0009-75; Manufactured by Gebauer Company, Cleveland, Ohio Terminated |
LFD | K981693 |
| Jul 20, 2004 | Gebauer Co Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland, OH. Terminated |
LFD | K981693 |