EWL · Class II · 21 CFR 874.3730

FDA Product Code EWL: Prosthesis, Laryngeal (taub)

Leading manufacturers include Bivona Medical Technologies, Atos Medical AB and Helix Medical, LLC.

40
Total
40
Cleared
112d
Avg days
1980
Since
40 devices
25–40 of 40
Cleared Apr 09, 1982
PERISCOPE VOICE PROSTHESIS
K820737
Bivona Medical Technologies
Ear, Nose, Throat · 22d
Cleared Nov 24, 1981
SILASTIC VOICE PROSTHESIS
K812864
Dow Corning Corp. Healthcare Industries Materials
Ear, Nose, Throat · 42d
Cleared Nov 24, 1981
BLOM-SINGER VOICE PROSTHESIS
K812982
Bivona Medical Technologies
Ear, Nose, Throat · 32d
Cleared Feb 05, 1981
PANJE VOICE PROSTHESIS
K810020
Xomed, Inc.
Ear, Nose, Throat · 31d
Cleared Mar 25, 1980
BLOM-SINGER DUCKBILL VOICE PROSTHESIS
K800563
Bivona Medical Technologies
Ear, Nose, Throat · 12d