EWLClass II

Prosthesis, Laryngeal (Taub)

21 CFR 874.3730 / Ear, Nose, Throat

EWL is the FDA product code for Prosthesis, Laryngeal (Taub), a class II device type, regulated under 21 CFR 874.3730. As of 2026-09-10, FDA records hold 40 510(k) clearances under this code, the most recent dated 2024-12-18, and 4 recalls.

Classification record

Product code: EWL
Device name: Prosthesis, Laryngeal (Taub)
Regulation: 21 CFR 874.3730
Device class: Class II
Review panel: Ear, Nose, Throat
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 40
Ingested recalls: 4

Clearances, product code EWL

By decision year

40 clearances under product code EWL with a decision year between 1980 and 2024, 1994 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code EWL by decision year
Year	Clearances
1980	1
1981	3
1982	2
1983	3
1984	1
1985	1
1986	3
1987	1
1988	1
1990	2
1991	1
1992	3
1993	2
1994	4
1997	1
1998	1
1999	1
2002	1
2004	1
2008	1
2009	1
2010	2
2013	1
2014	1
2024	1

Applicants with the most clearances

Product code EWL

Applicants holding the most 510(k) clearances under product code EWL
Applicant	Clearances
Freudenberg Medical, LLC	13
Atos Medical AB	8
Bivona Medical Technologies	8
American V. Mueller	2
Hood Laboratories	2
C.R. Bard Inc	1
Dacomed Corp.	1
Dow Corning Corp. Healthcare Industries Materials	1
E. Benson Hood Lab, Inc.	1
Exmoor Plastics Limited	1

Companies listing this code with FDA

Companies whose registered establishments list this code