EWL — Prosthesis, Laryngeal (Taub)

Class 2

Medical Specialty

Review Panel

Submission Type

FDA Authorisations (40)

Device Name	Manufacturer	K-Number	Decision Date
FirstFit Surgical Kit	Freudenberg Medical, LLC	K240763	2024-12-18
PROVOX FREEHANDS FLEXIVOICE	Atos Medical AB	K141380	2014-09-26
PROVOX VEGA PUNCTURE SET	Atos Medical AB	K131947	2013-10-18
PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM)	Atos Medical AB	K092593	2010-10-14
BLOM-SINGER INDWELLING TEP OCCLUDER	Helix Medical, LLC	K093258	2010-03-03
PROVOX VEGA, MODEL 8130-8135	Atos Medical AB	K090455	2009-06-05
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES	Helix Medical, LLC	K082206	2008-09-04
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134	Atos Medical AB	K043138	2004-11-22
PROVOX FREEHANDS HME, MODEL 7710	Atos Medical AB	K022125	2002-07-30
BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS	Helix Medical, Inc.	K991587	1999-06-25
VOICE MASTER PROSTHESIS	E. Benson Hood Lab, Inc.	K974132	1998-02-25
PROVOX 2 VOICE PROSTHESIS SYSTEM	Atos Medical AB	K971244	1997-06-06
INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE	Helix Medical, Inc.	K945287	1994-12-09
INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE	Helix Medical, Inc.	K945288	1994-12-02
PROVOX(TM) VOICE PROSTHESIS	Atos Medical AB	K940638	1994-06-22
BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES	Helix Medical, Inc.	K932120	1994-04-15
BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET	Helix Medical, Inc.	K932163	1993-12-15
BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S.	Helix Medical, Inc.	K930105	1993-05-17
BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET	Helix Medical, Inc.	K920090	1992-09-10
SINGH SPEECH SYSTEM (SERIES 'SSS')	Exmoor Plastics , Ltd.	K912486	1992-09-04

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