ETB · Class II · 21 CFR 874.3450

FDA Product Code ETB: Prosthesis, Partial Ossicular Replacement

Leading manufacturers include Gyrus Ent LLC, Grace Medical, Inc. and Smith & Nephew Richards, Inc..

74
Total
74
Cleared
77d
Avg days
1976
Since
74 devices
25–48 of 74
Cleared Oct 08, 1997
PARTIAL/TOTAL/POROUS POLYETHYLENE OSSICULAR REPLACEMENT
K972815
Grace Medical, Inc.
Ear, Nose, Throat · 72d
Cleared Sep 05, 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS (PORP)
K972734
Mednet Locator, Inc.
Ear, Nose, Throat · 45d
Cleared Sep 05, 1997
CAUSSE PISTON
K972737
Mednet Locator, Inc.
Ear, Nose, Throat · 45d
Cleared Aug 04, 1997
BELL PROSTHESIS (PARTIAL)
K972492
Heinz Kurz
Ear, Nose, Throat · 33d
Cleared Mar 10, 1997
ESTERM MALLEUS TOTAL AND PARTIAL MIDDLE EAR PROSTHESIS
K964909
Xomed, Inc.
Ear, Nose, Throat · 91d
Cleared Jan 22, 1997
RICHARDS TOTAL/PARTIAL PROSTHESIS
K962564
Gyrus Ent LLC
Ear, Nose, Throat · 205d
Cleared Jan 02, 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K964798
Anthony D. Prescott
Ear, Nose, Throat · 34d
Cleared Oct 10, 1996
PARTIAL & TOTAL OSSICULAR REPLACEMENT PROSTHESIS
K963752
Grace Medical, Inc.
Ear, Nose, Throat · 22d
Cleared May 14, 1996
POLY/PLATINUM WIRE PISTON
K945105
Micromed Development Corp.
Ear, Nose, Throat · 574d
Cleared Jun 16, 1995
RICHARDS PORP
K952481
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 17d
Cleared Mar 15, 1995
HAPEX MALLEABLE PORP
K950885
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 15, 1995
HAPEX PORP
K950886
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 15, 1995
HAPEX INCUS
K950887
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 15, 1995
HAPES MALLEABLE INCUS STAPES
K950984
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 12d
Cleared Mar 08, 1993
INCUDOSTAPEDIAL JOINT
K925443
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 131d
Cleared Dec 04, 1991
WEHRS INCUS AND INCUS-STAPES PROSTHESES
K910685
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 288d
Cleared Jan 13, 1989
BUCKET PROSTHESIS PORP
K883727
Treace Medical, Inc.
Ear, Nose, Throat · 135d
Cleared Jul 02, 1987
XOMED PLATINUM WIRE TEFLON PISTION
K872112
Xomed, Inc.
Ear, Nose, Throat · 31d
Cleared Apr 15, 1987
PROSTHESIS WIRE
K870766
Treace Medical, Inc.
Ear, Nose, Throat · 48d
Cleared Jul 14, 1986
INCUS/STAPES PROSTHESIS
K861369
Richards Medical Co., Inc.
Ear, Nose, Throat · 94d
Cleared Jul 11, 1986
MICROTEK STAINLESS STEEL PISTON
K860460
Microtek Medical, Inc.
Ear, Nose, Throat · 155d
Cleared Feb 26, 1985
INCUS PROSTHESIS
K844961
Richards Medical Co., Inc.
Ear, Nose, Throat · 67d
Cleared Jul 06, 1984
CAUSSE SPONGE BOAT
K841353
Treace Medical, Inc.
Ear, Nose, Throat · 95d
Cleared Dec 03, 1982
FISCH MODIFIED TEF-WIRE PISTON
K823429
Treace Medical, Inc.
Ear, Nose, Throat · 17d