ETB · Class II · 21 CFR 874.3450

FDA Product Code ETB: Prosthesis, Partial Ossicular Replacement

Leading manufacturers include Smith & Nephew Richards, Inc., Treace Medical, Inc. and Richard'S Medical Equip., Inc..

74
Total
74
Cleared
77d
Avg days
1976
Since
74 devices
25–48 of 74
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