# Gebauer Co.

> Medical device manufacturer record on deviCERTS, compiled from public registries. Gebauer Co. is a medical device manufacturer, with 23 devices listed in FDA GUDID and FDA 510(k) (FDA Unclassified) and 9 FDA recalls as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/gebauer-co>
- Also registered as: GEBAUER COMPANY
- Country: United States (from the FDA registration address)
- Role: Manufacturer
- Registrations: FDA
- FDA FEI: 1519179

## Figures

- Devices: 23
- FDA recalls (matched to the firm by name): 9

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 12, FDA 510(k) 11
- Device classes: FDA Unclassified 23

## Devices

The first 23 of 23, in the order of the canonical page, which lists them all.

- [Gebauer's Pain Ease One 0386-0008-05](https://devicerts.com/devices/gebauers-pain-ease-one-0386-0008-05) · Unclassified · GUDID · status: Active
- [Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)](https://devicerts.com/devices/gebauers-pain-ease-topical-anesthetic-skin-refrigerant-mist-mly-k260870) · ref K260870 · Unclassified · 510(k) · status: Active · decision 2026-08-27
- [Gebauer's Ethyl Chloride Fine Spray Accu-Stream 360 0386-0001-13](https://devicerts.com/devices/gebauers-ethyl-chloride-fine-spray-accu-stream-360-0386-0001-13) · Unclassified · GUDID · status: Active
- [Gebauer's Pain Ease Medium Stream 0386-0008-03](https://devicerts.com/devices/gebauers-pain-ease-medium-stream-0386-0008-03) · Unclassified · GUDID · status: Active
- [Gebauer's Pain Ease Mist Spray 0386-0008-02](https://devicerts.com/devices/gebauers-pain-ease-mist-spray-0386-0008-02) · Unclassified · GUDID · status: Active
- [Gebauer's Ethyl Chloride Fine Spray 0386-0001-04](https://devicerts.com/devices/gebauers-ethyl-chloride-fine-spray-0386-0001-04) · Unclassified · GUDID · status: Active
- [Gebauer's Spray and Stretch 0386-0004-04](https://devicerts.com/devices/gebauers-spray-and-stretch-0386-0004-04) · Unclassified · GUDID · status: Active
- [Gebauer's Ethyl Chloride Medium Spray Accu-Stream 360 0386-0001-11](https://devicerts.com/devices/gebauers-ethyl-chloride-medium-spray-accu-stream-360-0386-0001-11) · Unclassified · GUDID · status: Active
- [Gebauer's Ethyl Chloride Mist Spray 0386-0001-02](https://devicerts.com/devices/gebauers-ethyl-chloride-mist-spray-0386-0001-02) · Unclassified · GUDID · status: Active
- [Gebauer's Instant Ice 0386-0010-01](https://devicerts.com/devices/gebauers-instant-ice-0386-0010-01) · Unclassified · GUDID · status: Active
- [Gebauer's Pain Ease Mist Spray 0386-0008-01](https://devicerts.com/devices/gebauers-pain-ease-mist-spray-0386-0008-01) · Unclassified · GUDID · status: Active
- [Gebauer's Pain Ease Medium Stream 0386-0008-04](https://devicerts.com/devices/gebauers-pain-ease-medium-stream-0386-0008-04) · Unclassified · GUDID · status: Active
- [Gebauer's Ethyl Chloride Medium Spray 0386-0001-03](https://devicerts.com/devices/gebauers-ethyl-chloride-medium-spray-0386-0001-03) · Unclassified · GUDID · status: Active
- [Salivart Oral Moisturizer Model Number 03866-009-75 Salivart Oral Moisturizer Model Number 0386-000-25](https://devicerts.com/devices/salivart-oral-moisturizer-model-number-03866-009-75-salivart-lfd) · ref K981693 · Unclassified · 510(k) · status: Active · decision 2001-08-06
- [Gebauer's Skin Refrigerant (Mist Stream), Gebauer's Skin Refrigerant (Stream Spray), Models P/N 0386-0010-07](https://devicerts.com/devices/gebauers-skin-refrigerant-mist-stream-gebauers-skin-refriger-mly) · ref K032671 · Unclassified · 510(k) · status: Active · decision 2004-03-17
- [Gebauer's Chloride Fine Nozze](https://devicerts.com/devices/gebauers-chloride-fine-nozze-mly) · ref K991514 · Unclassified · 510(k) · status: Active · decision 1999-07-16
- [Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)](https://devicerts.com/devices/gebauers-pain-ease-topical-anesthetic-skin-refrigerant-mist-mly) · ref K172028 · Unclassified · 510(k) · status: Active · decision 2017-10-27
- [Fluori Methane Ss- A Vapocoolant/Skin Ref. Device](https://devicerts.com/devices/fluori-methane-ss-a-vapocoolant-skin-ref-device-mly) · ref K930915 · Unclassified · 510(k) · status: Active · decision 1994-09-29
- [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](https://devicerts.com/devices/ethyl-chloride-medium-jet-stream-ethyl-chloride-fine-pinpoin-mly) · ref K190161 · Unclassified · 510(k) · status: Active · decision 2019-05-07
- [Gebauer's Fluori-Methane, Model 0386-0003-04](https://devicerts.com/devices/gebauers-fluori-methane-model-0386-0003-04-mly) · ref K001624 · Unclassified · 510(k) · status: Active · decision 2001-01-25
- [Gebauer's Skin Refrigerant (Mist Spray), Model P/N 0386-0010-07, Gebauer's Skin Refrigerent (Medium Spray), Model P/N-03](https://devicerts.com/devices/gebauers-skin-refrigerant-mist-spray-model-p-n-0386-0010-07-mly) · ref K031036 · Unclassified · 510(k) · status: Active · decision 2003-07-10
- [Gebauer's Fluro Ethyl, Model 0386-0002-09](https://devicerts.com/devices/gebauers-fluro-ethyl-model-0386-0002-09-mly) · ref K002596 · Unclassified · 510(k) · status: Active · decision 2001-02-15
- [Gebauer's Instant Ice](https://devicerts.com/devices/gebauers-instant-ice-mly) · ref K021726 · Unclassified · 510(k) · status: Active · decision 2002-12-12

## FDA recalls (matched by name, newest first)

- Z-0218-2009 · Unclassified (pre-2012) · Terminated · initiated 2008-09-03 · product code MLY: 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.
- Z-1057-2007 · Unclassified (pre-2012) · Terminated · initiated 2007-04-17 · product code MLY: Mold contamination
- Z-1058-2007 · Unclassified (pre-2012) · Terminated · initiated 2007-04-17 · product code MLY: Mold contamination
- Z-1059-2007 · Unclassified (pre-2012) · Terminated · initiated 2007-04-17 · product code MLY: Mold contamination
- Z-1060-2007 · Unclassified (pre-2012) · Terminated · initiated 2007-04-17 · product code MLY: Mold contamination
- Z-1061-2007 · Unclassified (pre-2012) · Terminated · initiated 2007-04-17 · product code MLY: Mold contamination
- Z-1062-2007 · Unclassified (pre-2012) · Terminated · initiated 2007-04-17 · product code MLY: Mold contamination
- Z-0497-2007 · Unclassified (pre-2012) · Terminated · initiated 2007-01-19 · product code LFD: Microbial Contamination-certain lots of product failed USP \<61\> Microbial Limits Testing for total aerobic count during 6 month stability testing.
- Z-0641-04 · Unclassified (pre-2012) · Terminated · initiated 2004-02-23 · product code LFD: The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty.

## Source and citation

- Cite as: Gebauer Co. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/gebauer-co (data as of 2026-11-15).
- Data sources: [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/gebauer-co.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/gebauer-co
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.