ETD · Class II · 21 CFR 874.3880

FDA Product Code ETD: Tube, Tympanostomy

Leading manufacturers include Exmoor Plastics , Ltd., Xomed, Inc. and Treace Medical, Inc..

116
Total
116
Cleared
85d
Avg days
1976
Since
116 devices
25–48 of 116
Cleared Jul 15, 1998
TYMPANOSTOMY TUBE
K981575
Grace Medical, Inc.
Ear, Nose, Throat · 72d
Cleared May 13, 1998
PFLEIDERER'S INTRATYMPANIC CATHETER
K974008
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 208d
Cleared Mar 23, 1998
ROUND WINDOW E-CATH
K973740
Neuro-Biometrix, Inc.
Ear, Nose, Throat · 173d
Cleared Dec 12, 1997
SHAH PERMAVENT
K974007
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 52d
Cleared Nov 04, 1997
TUBINGEN TYMPANIC VENTILATION TUBE, TYMPANIC VENTILATION TUBES WITH ENE/S, DIABOLO TYMPANIC VENTILATION TUBE, MINIMAL T)
K973226
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 69d
Cleared Jul 29, 1997
MYRINGOTOMY TUBE
K972126
Mednet Locator, Inc.
Ear, Nose, Throat · 54d
Cleared Jul 23, 1997
MYRINGOTOMY TUBE
K971943
Mednet Locator, Inc.
Ear, Nose, Throat · 57d
Cleared Jul 23, 1997
MYRINGOTOMY TUBE - BOBBIN WITH TAB
K972400
Mednet Locator, Inc.
Ear, Nose, Throat · 48d
Cleared May 29, 1997
TYMPANOSTOMY VENTILATION TUBE
K971454
Ikonos Corp.
Ear, Nose, Throat · 38d
Cleared May 16, 1997
TM MICRO-CATHETERS
K971124
Xomed, Inc.
Ear, Nose, Throat · 50d
Cleared Mar 10, 1997
ROUND WINDOW CATH
K965115
Neuro-Biometrix, Inc.
Ear, Nose, Throat · 80d
Cleared Feb 11, 1997
HOFFMAN H/A COATED LONG-TERM VENTILATION TUBE WITH LINER
K963727
Medtronic Xomed
Ear, Nose, Throat · 148d
Cleared Jul 01, 1996
ACTIVENT ANTIMICROBIAL VENTILATION TUBES
K961873
Xomed, Inc.
Ear, Nose, Throat · 47d
Cleared Jun 11, 1996
TYMPANOSTOMY VENTILATION TUBE
K961945
Advanced Microbotics Corp.
Ear, Nose, Throat · 22d
Cleared Apr 03, 1996
TYMPANOSTOMY VENTILATION TUBE
K960742
Advanced Microbotics Corp.
Ear, Nose, Throat · 40d
Cleared Feb 26, 1996
VENTILATION TUBES
K960477
Smith & Nephew, Inc.
Ear, Nose, Throat · 25d
Cleared Jan 17, 1996
MISTEN MEDICAL REUTER BOBBIN STYLE VENT TUBE
K955616
Misten Medical Corp.
Ear, Nose, Throat · 37d
Cleared Dec 21, 1995
TYMPANOSTOMY TUBE
K955447
Trebay Medical Corp.
Ear, Nose, Throat · 22d
Cleared Nov 15, 1995
AT2 & DOYLE STYLE (C-FLEX) VENT TUBES
K954795
Trebay Medical Corp.
Ear, Nose, Throat · 28d
Cleared Oct 24, 1995
TYMPANOSTOMY TUBE
K953802
Bluff City Medical Technologies, Inc.
Ear, Nose, Throat · 78d
Cleared Sep 12, 1995
TYMPASNOSTOMY TUBE
K953993
Hampton Precision Products, Inc.
Ear, Nose, Throat · 19d
Cleared Mar 14, 1995
TYMPANOSTOMY (VENTILATION) TUBE
K941407
Xomed-Treace, Inc.
Ear, Nose, Throat · 356d
Cleared Oct 11, 1994
TYMPANOSTOMY TUBE
K943325
Grace Medical, Inc.
Ear, Nose, Throat · 92d
Cleared Sep 16, 1994
COLLAR BUTTON VENTURI VENT TUBE
K943848
Micromed Development Corp.
Ear, Nose, Throat · 43d