Gebauer Co.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K190161Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl ChlMay 7, 2019
K172028Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)October 27, 2017
K032671GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM SPRAY), MODELS P/N 0386March 17, 2004
K031036GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S SKIN REFRIGERENT (MEDIUM July 10, 2003
K021726GEBAUER'S INSTANT ICEDecember 12, 2002
K981693SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-August 6, 2001
K002596GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09February 15, 2001
K001624GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04January 25, 2001
K991514GEBAUER'S CHLORIDE FINE NOZZEJuly 16, 1999
K930915FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICESeptember 29, 1994