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Gebauer Co.

Also registered as GEBAUER COMPANY

United Statesfrom the FDA registration address FDA FEI 1519179

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.

Devices
23
Registrations
FDA
FDA recalls
9

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA GUDID 12
  • FDA 510(k) 11

A device listed in two registries counts in both.

Device classes
  • FDA Unclassified 23
FDA recalls
Identifiers
  • FDA FEI 1519179

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

Catalogue23

Newest first, rows 1-23 of 23

Search and filter all 23 devices
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Rows 1-23 of 23

Company details

FDA FEI number
1519179
Address
4444 E. 153RD ST., Cleveland, OH, 44128

FDA recalls9

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2008

    • 3 Sep 2008 Z-0218-2009 Unclassified (pre-2012) Terminated 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. Distribution: Nationwide Distribution. Submission number: K002596

  • 2007

    • 17 Apr 2007 Z-1057-2007 Unclassified (pre-2012) Terminated Mold contamination Distribution: Nationwide Submission number: K032671
    • 17 Apr 2007 Z-1058-2007 Unclassified (pre-2012) Terminated Mold contamination Distribution: Nationwide Submission number: K031036
    • 17 Apr 2007 Z-1059-2007 Unclassified (pre-2012) Terminated Mold contamination Distribution: Nationwide Submission number: K021726
    • 17 Apr 2007 Z-1060-2007 Unclassified (pre-2012) Terminated Mold contamination Distribution: Nationwide Submission number: K021726
    • 17 Apr 2007 Z-1061-2007 Unclassified (pre-2012) Terminated Mold contamination Distribution: Nationwide Submission number: K032671
    • 17 Apr 2007 Z-1062-2007 Unclassified (pre-2012) Terminated Mold contamination Distribution: Nationwide Submission number: K032671
    • 19 Jan 2007 Z-0497-2007 Unclassified (pre-2012) Terminated Microbial Contamination-certain lots of product failed USP <61> Microbial Limits Testing for total aerobic count during 6 month stability testing. Distribution: The product was distributed throughout the U.S. to wholesalers, retail accounts (i.e. pharmacies, dental offices, and…
      Full distribution text The product was distributed throughout the U.S. to wholesalers, retail accounts (i.e. pharmacies, dental offices, and medical facilities) and full size samples of product were given away at trade shows to medical, and dental offices and some end users consumers). A total of 240 units of product derived from Lot Code: 06AA001, were distributed to a single Canadian distributor under the assigned Lot Code: 06BB002
      Submission number: K981693

  • 2004

    • 23 Feb 2004 Z-0641-04 Unclassified (pre-2012) Terminated The actuator valve is defective, which may allow the valve to remain open after use and continue to spray until the can is empty. Distribution: The product was shipped to consignees located nationwide. Submission number: K981693

Frequently asked questions

How many devices does Gebauer Co. have in the registry?

The registry currently lists 23 devices for Gebauer Co.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Gebauer Co.'s devices?

Among its 23 most recently registered devices, Gebauer Co. has devices listed in FDA 510(k) (11 devices) and FDA GUDID (12 devices). A device can be listed in more than one registry, so these counts overlap.

Are there FDA recall records for Gebauer Co.?

FDA recall records list 9 recalls initiated by Gebauer Co., the most recent initiated on 3 Sep 2008. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Gebauer Co. in the registry?

The most recently registered devices listed for Gebauer Co. include Gebauer's Pain Ease One 0386-0008-05, Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray), Gebauer's Ethyl Chloride Fine Spray Accu-Stream 360 0386-0001-13 and Gebauer's Pain Ease Medium Stream 0386-0008-03.

Generated automatically from registry data and not verified by a human reviewer.