Prosthesis, Laryngeal (Taub)

FDA product code EWL · 39 cleared devices

Class 2 Ear, Nose, Throat

Regulation: 21 CFR 874.3730
Review panel: EN
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1980-03-25 – 2024-12-18

EWL 2024-12-18

FirstFit Surgical Kit

Applicant Freudenberg Medical, LLC

K number K240763

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EWL 2013-10-18

PROVOX VEGA PUNCTURE SET

Applicant Atos Medical AB

K number K131947

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EWL 2010-10-14

PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)

Applicant Atos Medical AB

K number K092593

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EWL 2010-03-03

BLOM-SINGER INDWELLING TEP OCCLUDER

Applicant Helix Medical, LLC

K number K093258

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EWL 2009-06-05

PROVOX VEGA, MODEL 8130-8135

Applicant Atos Medical AB

K number K090455

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EWL 2008-09-04

BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES

Applicant Helix Medical, LLC

K number K082206

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EWL 2004-11-22

PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134

Applicant Atos Medical AB

K number K043138

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EWL 2002-07-30

PROVOX FREEHANDS HME, MODEL 7710

Applicant Atos Medical AB

K number K022125

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EWL 1999-06-25

BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS

Applicant Helix Medical, Inc.

K number K991587

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EWL 1998-02-25

VOICE MASTER PROSTHESIS

Applicant E. Benson Hood Lab, Inc.

K number K974132

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EWL 1997-06-06

PROVOX 2 VOICE PROSTHESIS SYSTEM

Applicant Atos Medical AB

K number K971244

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EWL 1994-12-09

INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE

Applicant Helix Medical, Inc.

K number K945287

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EWL 1994-12-02

INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE

Applicant Helix Medical, Inc.

K number K945288

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EWL 1994-06-22

PROVOX(TM) VOICE PROSTHESIS

Applicant Atos Medical AB

K number K940638

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EWL 1994-04-15

BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES

Applicant Helix Medical, Inc.

K number K932120

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EWL 1993-12-15

BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET

Applicant Helix Medical, Inc.

K number K932163

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EWL 1993-05-17

BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.

Applicant Helix Medical, Inc.

K number K930105

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EWL 1992-09-10

BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET

Applicant Helix Medical, Inc.

K number K920090

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EWL 1992-09-04

SINGH SPEECH SYSTEM (SERIES 'SSS')

Applicant Exmoor Plastics , Ltd.

K number K912486

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EWL 1992-06-29

BIVONA-COLORADO VOICE PROSTHESIS

Applicant Bivona Medical Technologies

K number K915761

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EWL 1991-02-28

BLOM-SINGER SHOWER GUARD

Applicant Helix Medical, Inc.

K number K904729

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EWL 1990-08-01

BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT

Applicant Helix Medical, Inc.

K number K902112

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EWL 1990-06-14

BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT

Applicant Helix Medical, Inc.

K number K900518

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EWL 1988-05-13

BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS

Applicant Bivona Medical Technologies

K number K881011

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EWL 1987-06-08

ESKA-HERRMANN TRACHEOSTOMY VALVE

Applicant C.R. Bard, Inc.

K number K871885

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EWL 1986-04-02

BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS

Applicant Bivona Medical Technologies

K number K861088

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EWL 1986-03-17

DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS

Applicant Dacomed Corp.

K number K854118

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EWL 1986-03-12

FLEXIBLE GRASPING FORCEPS

Applicant Hood Laboratories

K number K854112

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EWL 1985-12-13

THE GRONINGEN VOICE PROSTHESIS

Applicant Hood Laboratories

K number K853940

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EWL 1984-08-17

BLOM-SINGER LOW PRESSURE VOICE PROSTHES

Applicant American V. Mueller

K number K842896

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EWL 1983-12-23

DUCKBILL VOICE PROSTHESIS & TRACHEO

Applicant American V. Mueller

K number K832967

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EWL 1983-09-29

BLAISE-RATHAEL VOICE PROSTHESIS

Applicant Richards Medical Co., Inc.

K number K832852

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EWL 1983-01-07

LOW PRESSURE BLOM-SINGER VOICE PROSTHES

Applicant Bivona Medical Technologies

K number K823749

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EWL 1982-07-26

BLOW-SINGER TRACHEOSTOMA VALVE

Applicant Bivona Medical Technologies

K number K821568

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EWL 1982-04-09

PERISCOPE VOICE PROSTHESIS

Applicant Bivona Medical Technologies

K number K820737

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EWL 1981-11-24

BLOM-SINGER VOICE PROSTHESIS

Applicant Bivona Medical Technologies

K number K812982

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EWL 1981-11-24

SILASTIC VOICE PROSTHESIS

Applicant Dow Corning Corp. Healthcare Industries Materials

K number K812864

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EWL 1981-02-05

PANJE VOICE PROSTHESIS

Applicant Xomed, Inc.

K number K810020

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EWL 1980-03-25

BLOM-SINGER DUCKBILL VOICE PROSTHESIS

Applicant Bivona Medical Technologies

K number K800563

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