Data / Medical devices / United States / Gebauer Co.
Gebauer Co.: FDA-registered device maker in Cleveland, OH, United States, 4 510(k) clearances
Gebauer Co. is registered with the FDA (registration 1519179) in Cleveland, OH, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated May 7, 2019. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1519179
- Address
- 4444 E. 153RD ST., Cleveland, OH, United States, 44128
- Owner or operator
- GEBAUER CO. (9002736)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 11, 2013
- Registered through
- 2026
- Brand names listed
- Gebauer's Ethyl Chloride, Gebauer's Instant Ice, Gebauer's Pain Ease, Gebauer's Spray and Stretch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Vapocoolant Device | MLY | U | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 7, 2019 | K190161 | Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray | MLY | Substantially Equivalent | Gebauer Company | accessdata.fda.gov |
| October 27, 2017 | K172028 | Gebauers Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | MLY | Substantially Equivalent | Gebauer Company | accessdata.fda.gov |
| July 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 | MLY | Substantially Equivalent | Gebauer Co. | accessdata.fda.gov |
| December 12, 2002 | K021726 | GEBAUER'S INSTANT ICE | MLY | Substantially Equivalent | Gebauer Co. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 3, 2008 | 49463 | Not yet classified | Terminated | 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 vapocoolant (skin refrigerant), to | 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 normal inverted position from the product's actuator. The product can also leak coolant from the side of the valve onto the fingers of the user. | accessdata.fda.gov |
| April 17, 2007 | 37778 | Not yet classified | Terminated | 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) | Mold contamination | accessdata.fda.gov |
| January 19, 2007 | 37150 | Not yet classified | Terminated | 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 | Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing. | accessdata.fda.gov |
| February 23, 2004 | 28415 | Not yet classified | Terminated | Salvart Oral Moisturizer, 2.5 fl.oz. aerosol cans, OTC, Item Number 0386-0009-75. Distributed by: Gebauer Co., Cleveland, OH. | The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty. | accessdata.fda.gov |
Compare with other makers
Updated May 7, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.