Gebauer Co
Cleveland, OH, US
GEBAUER CO. appears in FDA device records in Cleveland, OH. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Gebauer Co between 1994 and 2019. The busiest year on record is 2001, with 3. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1994 | 1 |
| 1999 | 1 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K172028 | Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray) | MLY | Substantially Equivalent | |
| K032671 | GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386-0010-07 | MLY | Substantially Equivalent | |
| 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 | |
| K021726 | GEBAUER'S INSTANT ICE | MLY | Substantially Equivalent | |
| K981693 | SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25 | LFD | Substantially Equivalent | |
| K002596 | GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09 | MLY | Substantially Equivalent | |
| K001624 | GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04 | MLY | Substantially Equivalent | |
| K991514 | GEBAUER'S CHLORIDE FINE NOZZE | MLY | Substantially Equivalent | |
| K930915 | FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE | MLY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1519179 | 1519179 | GEBAUER CO. | 4444 E. 153RD ST., Cleveland, OH 44128 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0218-2009 | 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), topical anesthetic intended to control the pain associated with minor surgical procedures, dermabrasion and injection. It is also effective in providing temporary relief from the pain associated with minor sports injuries. | 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. | Terminated | ||
| Z-1062-2007 | 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) | Mold contamination | Terminated | ||
| Z-1061-2007 | 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-0386-0008-03) | Mold contamination | Terminated | ||
| Z-1060-2007 | 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-(Product Number-0386-0010-01) | Mold contamination | Terminated | ||
| Z-1059-2007 | 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. (103.5ml) can.-(Product Number: 0386-0010-05-) | Mold contamination | Terminated | ||
| Z-1058-2007 | 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 relief of minor sporsts injuries. Rx only- 3.5 fl. oz. (103.5ml) can-Product Number 0386-0004-04 | Mold contamination | Terminated | ||
| Z-1057-2007 | 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 | Terminated | ||
| Z-0497-2007 | 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. | Terminated | ||
| Z-0641-04 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain