ETB · Class II · 21 CFR 874.3450

FDA Product Code ETB: Prosthesis, Partial Ossicular Replacement

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

74
Total
74
Cleared
77d
Avg days
1976
Since
74 devices
49–72 of 74
Cleared Dec 03, 1982
CAUSSE TEF-PISTON
K823439
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Dec 03, 1982
MCGEE MODIFIED STAINLESS STEEL PISTON
K823440
Treace Medical, Inc.
Ear, Nose, Throat · 17d
Cleared Dec 19, 1980
SHEA LOCKING BAIL PROSTHESIS
K802873
Richard'S Medical Equip., Inc.
Ear, Nose, Throat · 35d
Cleared Nov 12, 1980
SCHURING OSSICLE CUP & COLUMELLA PROSTH.
K802431
Richard'S Medical Equip., Inc.
Ear, Nose, Throat · 37d
Cleared Oct 05, 1976
TRAPEZE PLATINUM RIBBON LOOP, OTOLOGY
K760434
Richard'S Medical Equip., Inc.
Ear, Nose, Throat · 50d
Cleared Oct 05, 1976
CAUSSE MODIFIED TEFLON PISTON, OTOLOGY
K760437
Richard'S Medical Equip., Inc.
Ear, Nose, Throat · 50d
Cleared Sep 27, 1976
PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT
K760435
Richard'S Medical Equip., Inc.
Ear, Nose, Throat · 42d