Medical Device Manufacturer · US , Washington , DC

Gebauer Co. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1994

Recent clearances: SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gebauer Co. Physical Medicine ✕

7 devices

1-7 of 7

Cleared Mar 17, 2004

GEBAUER'S SKIN REFRIGERANT (MIST STREAM), GEBAUER'S SKIN REFRIGERANT (STREAM...

Physical Medicine · 201d

Cleared Jul 10, 2003

GEBAUER'S SKIN REFRIGERANT (MIST SPRAY), MODEL P/N 0386-0010-07, GEBAUER'S...

Physical Medicine · 100d

Cleared Dec 12, 2002

GEBAUER'S INSTANT ICE

Physical Medicine · 202d

Cleared Feb 15, 2001

GEBAUER'S FLURO ETHYL, MODEL 0386-0002-09

Physical Medicine · 178d

Cleared Jan 25, 2001

GEBAUER'S FLUORI-METHANE, MODEL 0386-0003-04

Physical Medicine · 244d

Cleared Jul 16, 1999

GEBAUER'S CHLORIDE FINE NOZZE

Physical Medicine · 77d

Cleared Sep 29, 1994

FLUORI METHANE SS- A VAPOCOOLANT/SKIN REF. DEVICE

Physical Medicine · 583d

Data Source

Sourced from the FDA 510(k) public files . 175,972 total devices indexed.

Last updated: Sep 09, 2026