MUI · Class II · 21 CFR 892.1570

FDA Product Code MUI: Media, Coupling, Ultrasound

Leading manufacturers include Sonotech, Inc., Pharmaceutical Innovations, Inc. and Sheathing Technologies, Inc..

35
Total
35
Cleared
175d
Avg days
1982
Since
35 devices
25–35 of 35
Cleared Sep 20, 2007
EMBRACE GEL
K072515
Orison Corporation
Radiology · 13d
Cleared Nov 05, 2004
ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT
K042619
Sonotech, Inc.
Radiology · 42d
Cleared Aug 04, 2004
ULTRABIO
K033178
Sonotech, Inc.
Radiology · 308d
Cleared Dec 08, 2003
AUTOGEL PAD
K031018
Rich-Mar Corp.
Radiology · 252d
Cleared Jul 23, 2003
SCANLUBE
K031222
Sonotech, Inc.
Radiology · 97d
Cleared Jul 18, 2003
SCANTEC PAD
K031894
Sonotech, Inc.
Radiology · 29d
Cleared May 23, 2003
ULTRAEKOGEL MODELS EK 2000 & EK 2001
K030889
Inmed Ltda.
Radiology · 63d
Cleared May 16, 2002
VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA
K020956
Microtek Medical, Inc.
Radiology · 52d
Cleared May 15, 2002
UNI-PATCH ULTRASOUND COUPLING GEL
K021132
The Ludlow Company LP
Radiology · 36d
Cleared Feb 25, 2002
WAVELENGHT ULTRASOUND LOTION
K013212
National Therapy Products, Inc.
Radiology · 153d
Cleared Apr 16, 1982
POLYSONIC ULTRASOUND LOTION
K827296
Parker Laboratories, Inc.
Radiology · 17d