FZD · Class II · 21 CFR 878.3590

FDA Product Code FZD: Prosthesis, Ear, Internal

Leading manufacturers include Implantech Associates, Inc., Richards Medical Co., Inc. and Porex Medical.

3
Total
3
Cleared
142d
Avg days
1985
Since

FDA 510(k) Cleared Prosthesis, Ear, Internal Devices (Product Code FZD)

3 devices
1–3 of 3
Cleared Jul 18, 2018
ePTFE-Coated Auricular Implant
K172389
Implantech Associates, Inc.
General & Plastic Surgery · 344d
Cleared Oct 24, 1986
POREX(TM) EAR PROSTHESIS
K863939
Porex Medical
General & Plastic Surgery · 14d
Cleared Feb 26, 1985
CANAL WALL PROSTHESIS
K844960
Richards Medical Co., Inc.
General & Plastic Surgery · 67d

About Product Code FZD - Regulatory Context