EMX · Class I · 21 CFR 874.4100

FDA Product Code EMX: Balloon, Epistaxis

Leading manufacturers include Ultracell Medical Technologies, Inc., Boston Medical Products, Inc. and Bivona Medical Technologies.

47
Total
47
Cleared
107d
Avg days
1978
Since
47 devices
25–47 of 47
Cleared Feb 12, 1993
NASAL-SINUS PACKING
K924542
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 157d
Cleared Nov 30, 1992
ULTRACELL NASAL PACKING
K920358
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 308d
Cleared Jul 08, 1992
EPISTAXIS NASAL BALLOON CATHETER
K921199
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 118d
Cleared Aug 09, 1990
MODIFIED BIVONA EPISTAXIS CATHETER
K900583
Bivona Medical Technologies
Ear, Nose, Throat · 183d
Cleared Aug 17, 1984
FOX POST NASAL BALLOON CATHETER
K841040
Inmed Corp.
Ear, Nose, Throat · 158d
Cleared Jun 14, 1982
EPISTAXIS CATHETER/KIT
K821584
Bivona Medical Technologies
Ear, Nose, Throat · 13d
Cleared Jun 16, 1981
GOTTSCHALK NASOSTAT SLIM LINE, ADULT/SM.
K811496
Narco Scientific
Ear, Nose, Throat · 20d
Cleared Feb 21, 1980
NASOSTAT
K800175
Edward Weck, Inc.
Ear, Nose, Throat · 24d