KHJ · Class II · 21 CFR 874.3620

FDA Product Code KHJ: Polymer, Ent Synthetic-polyamide (mesh Or Foil Material)

Leading manufacturers include Ceremed , Inc., Xomed, Inc. and Curamedical, BV.

34
Total
34
Cleared
131d
Avg days
1991
Since
34 devices
25–34 of 34
Cleared Nov 03, 1998
EPIFILM OTOLOGIC LAMINA
K982870
Xomed, Inc.
Ear, Nose, Throat · 81d
Cleared Sep 18, 1998
XOMED SILICONE PRE-FORM BLOCKS
K982294
Xomed, Inc.
Ear, Nose, Throat · 80d
Cleared Jul 16, 1998
EXMOOR ATTIC AND MASTOID ANTRUM MIDDLE EAR IMPLANT (EMMETT CAMPBELL MD FACS PATTERN)
K972700
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 393d
Cleared Mar 04, 1998
VOCOM (VOCAL CORD MEDIALIZATION) IMPLANT
K974311
Gyrus Ent LLC
Ear, Nose, Throat · 107d
Cleared May 02, 1997
XOMED SILICONE BLOCK/STRIP
K970910
Xomed, Inc.
Ear, Nose, Throat · 51d
Cleared Jan 24, 1997
KARTUSH TM PATCHER
K964484
Xomed, Inc.
Ear, Nose, Throat · 78d
Cleared Nov 19, 1991
EXMOOR SILICONE RUBBER SHEET
K911503
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 230d