Atlas FDA

EWL

40 FDA 510(k) clearances · Product code

84 daysmedian time to decision
273 days90th percentile
40clearances measured

FDA profile

Official device name
Prosthesis, Laryngeal (Taub)
Device class
Class II (moderate risk)
Regulation
21 CFR 874.3730
Medical specialty
Ear, Nose, Throat
Adverse events (MAUDE)
2010: 4 · 2014: 7 · 2015: 11 · 2016: 16 · 2017: 15 · 2026: 17
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
FirstFit Surgical Kit (K240763)Freudenberg Medical, LLC2024-12-18
PROVOX FREEHANDS FLEXIVOICE (K141380)Atos Medical AB2014-09-26
PROVOX VEGA PUNCTURE SET (K131947)Atos Medical AB2013-10-18
PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) (K092593)Atos Medical AB2010-10-14
BLOM-SINGER INDWELLING TEP OCCLUDER (K093258)Helix Medical, LLC2010-03-03
PROVOX VEGA, MODEL 8130-8135 (K090455)Atos Medical AB2009-06-05
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES (K082206)Helix Medical, LLC2008-09-04
PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 (K043138)Atos Medical AB2004-11-22
PROVOX FREEHANDS HME, MODEL 7710 (K022125)Atos Medical AB2002-07-30
BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS (K991587)Helix Medical, Inc.1999-06-25
VOICE MASTER PROSTHESIS (K974132)E. Benson Hood Lab, Inc.1998-02-25
PROVOX 2 VOICE PROSTHESIS SYSTEM (K971244)Atos Medical AB1997-06-06
INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE (K945287)Helix Medical, Inc.1994-12-09
INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE (K945288)Helix Medical, Inc.1994-12-02
PROVOX(TM) VOICE PROSTHESIS (K940638)Atos Medical AB1994-06-22
BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES (K932120)Helix Medical, Inc.1994-04-15
BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET (K932163)Helix Medical, Inc.1993-12-15
BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. (K930105)Helix Medical, Inc.1993-05-17
BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET (K920090)Helix Medical, Inc.1992-09-10
SINGH SPEECH SYSTEM (SERIES 'SSS') (K912486)Exmoor Plastics , Ltd.1992-09-04
BIVONA-COLORADO VOICE PROSTHESIS (K915761)Bivona Medical Technologies1992-06-29
BLOM-SINGER SHOWER GUARD (K904729)Helix Medical, Inc.1991-02-28
BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT (K902112)Helix Medical, Inc.1990-08-01
BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT (K900518)Helix Medical, Inc.1990-06-14
BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS (K881011)Bivona Medical Technologies1988-05-13
ESKA-HERRMANN TRACHEOSTOMY VALVE (K871885)C.R. Bard, Inc.1987-06-08
BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS (K861088)Bivona Medical Technologies1986-04-02
DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS (K854118)Dacomed Corp.1986-03-17
FLEXIBLE GRASPING FORCEPS (K854112)Hood Laboratories1986-03-12
THE GRONINGEN VOICE PROSTHESIS (K853940)Hood Laboratories1985-12-13
BLOM-SINGER LOW PRESSURE VOICE PROSTHES (K842896)American V. Mueller1984-08-17
DUCKBILL VOICE PROSTHESIS & TRACHEO (K832967)American V. Mueller1983-12-23
BLAISE-RATHAEL VOICE PROSTHESIS (K832852)Richards Medical Co., Inc.1983-09-29
LOW PRESSURE BLOM-SINGER VOICE PROSTHES (K823749)Bivona Medical Technologies1983-01-07
BLOW-SINGER TRACHEOSTOMA VALVE (K821568)Bivona Medical Technologies1982-07-26
PERISCOPE VOICE PROSTHESIS (K820737)Bivona Medical Technologies1982-04-09
BLOM-SINGER VOICE PROSTHESIS (K812982)Bivona Medical Technologies1981-11-24
SILASTIC VOICE PROSTHESIS (K812864)Dow Corning Corp. Healthcare Industries Materials1981-11-24
PANJE VOICE PROSTHESIS (K810020)Xomed, Inc.1981-02-05
BLOM-SINGER DUCKBILL VOICE PROSTHESIS (K800563)Bivona Medical Technologies1980-03-25

Track EWL automatically

Every clearance here is in the API, with alerts when new ones post.