Panels › Ear, Nose, Throat › Product code EWL · Class 2
Prosthesis, Laryngeal (Taub)
Regulation 874.3730
0510(k)s in 12 months (40 all time)
2recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in EWL
| Company | 510(k)s | Recalls |
|---|---|---|
| Helix Medical, Inc. | 12 | 2 |
| Atos Medical AB | 8 | 0 |
| Bivona Medical Technologies | 8 | 0 |
| Freudenberg Medical, LLC | 1 | 2 |
| American V. Mueller | 2 | 0 |
| Hood Laboratories | 2 | 0 |
| C.R. Bard, Inc. | 1 | 0 |
| Dacomed Corp. | 1 | 0 |
| Dow Corning Corp. Healthcare Industries Materials | 1 | 0 |
| E. Benson Hood Lab, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 18, 2024 | K240763 | FirstFit Surgical Kit Freudenberg Medical, LLC | EWL |
| Sep 26, 2014 | K141380 | PROVOX FREEHANDS FLEXIVOICE Atos Medical AB, SE | EWL |
| Oct 18, 2013 | K131947 | PROVOX VEGA PUNCTURE SET Atos Medical AB, SE | EWL |
| Oct 14, 2010 | K092593 | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) Atos Medical AB, SE | EWL |
| Mar 3, 2010 | K093258 | BLOM-SINGER INDWELLING TEP OCCLUDER Helix Medical, LLC | EWL |
| Jun 5, 2009 | K090455 | PROVOX VEGA, MODEL 8130-8135 Atos Medical AB, SE | EWL |
| Sep 4, 2008 | K082206 | BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES Helix Medical, LLC | EWL |
| Nov 22, 2004 | K043138 | PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 Atos Medical AB, SE | EWL |
| Jul 30, 2002 | K022125 | PROVOX FREEHANDS HME, MODEL 7710 Atos Medical AB, SE | EWL |
| Jun 25, 1999 | K991587 | BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS Helix Medical, Inc. | EWL |
| Feb 25, 1998 | K974132 | VOICE MASTER PROSTHESIS E. Benson Hood Lab, Inc. | EWL |
| Jun 6, 1997 | K971244 | PROVOX 2 VOICE PROSTHESIS SYSTEM Atos Medical AB, SE | EWL |
| Dec 9, 1994 | K945287 | INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE Helix Medical, Inc. | EWL |
| Dec 2, 1994 | K945288 | INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE Helix Medical, Inc. | EWL |
| Jun 22, 1994 | K940638 | PROVOX(TM) VOICE PROSTHESIS Atos Medical AB, SE | EWL |
| Apr 15, 1994 | K932120 | BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES Helix Medical, Inc. | EWL |
| Dec 15, 1993 | K932163 | BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET Helix Medical, Inc. | EWL |
| May 17, 1993 | K930105 | BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. Helix Medical, Inc. | EWL |
| Sep 10, 1992 | K920090 | BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET Helix Medical, Inc. | EWL |
| Sep 4, 1992 | K912486 | SINGH SPEECH SYSTEM (SERIES 'SSS') Exmoor Plastics , Ltd., GB | EWL |
| Jun 29, 1992 | K915761 | BIVONA-COLORADO VOICE PROSTHESIS Bivona Medical Technologies | EWL |
| Feb 28, 1991 | K904729 | BLOM-SINGER SHOWER GUARD Helix Medical, Inc. | EWL |
| Aug 1, 1990 | K902112 | BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT Helix Medical, Inc. | EWL |
| Jun 14, 1990 | K900518 | BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT Helix Medical, Inc. | EWL |
| May 13, 1988 | K881011 | BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS Bivona Medical Technologies | EWL |
| Jun 8, 1987 | K871885 | ESKA-HERRMANN TRACHEOSTOMY VALVE C.R. Bard, Inc. | EWL |
| Apr 2, 1986 | K861088 | BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS Bivona Medical Technologies | EWL |
| Mar 17, 1986 | K854118 | DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS Dacomed Corp. | EWL |
| Mar 12, 1986 | K854112 | FLEXIBLE GRASPING FORCEPS Hood Laboratories | EWL |
| Dec 13, 1985 | K853940 | THE GRONINGEN VOICE PROSTHESIS Hood Laboratories | EWL |
| Aug 17, 1984 | K842896 | BLOM-SINGER LOW PRESSURE VOICE PROSTHES American V. Mueller | EWL |
| Dec 23, 1983 | K832967 | DUCKBILL VOICE PROSTHESIS & TRACHEO American V. Mueller | EWL |
| Sep 29, 1983 | K832852 | BLAISE-RATHAEL VOICE PROSTHESIS Richards Medical Co., Inc. | EWL |
| Jan 7, 1983 | K823749 | LOW PRESSURE BLOM-SINGER VOICE PROSTHES Bivona Medical Technologies | EWL |
| Jul 26, 1982 | K821568 | BLOW-SINGER TRACHEOSTOMA VALVE Bivona Medical Technologies | EWL |
| Apr 9, 1982 | K820737 | PERISCOPE VOICE PROSTHESIS Bivona Medical Technologies | EWL |
| Nov 24, 1981 | K812982 | BLOM-SINGER VOICE PROSTHESIS Bivona Medical Technologies | EWL |
| Nov 24, 1981 | K812864 | SILASTIC VOICE PROSTHESIS Dow Corning Corp. Healthcare Industries Materials | EWL |
| Feb 5, 1981 | K810020 | PANJE VOICE PROSTHESIS Xomed, Inc. | EWL |
| Mar 25, 1980 | K800563 | BLOM-SINGER DUCKBILL VOICE PROSTHESIS Bivona Medical Technologies | EWL |
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