FDA Product Code
FDA Product Code EWL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3730
510(k) Clearances — 40 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240763 | FirstFit Surgical Kit | Freudenberg Medical, LLC | 2024-12-18 | Traditional | PDF ↗ |
| K141380 | PROVOX FREEHANDS FLEXIVOICE | Atos Medical AB | 2014-09-26 | Traditional | PDF ↗ |
| K131947 | PROVOX VEGA PUNCTURE SET | Atos Medical AB | 2013-10-18 | Traditional | PDF ↗ |
| K092593 | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) | Atos Medical AB | 2010-10-14 | Traditional | PDF ↗ |
| K093258 | BLOM-SINGER INDWELLING TEP OCCLUDER | Helix Medical, LLC | 2010-03-03 | Special | PDF ↗ |
| K090455 | PROVOX VEGA, MODEL 8130-8135 | Atos Medical AB | 2009-06-05 | Traditional | PDF ↗ |
| K082206 | BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES | Helix Medical, LLC | 2008-09-04 | Special | PDF ↗ |
| K043138 | PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 | Atos Medical AB | 2004-11-22 | Special | PDF ↗ |
| K022125 | PROVOX FREEHANDS HME, MODEL 7710 | Atos Medical AB | 2002-07-30 | Special | PDF ↗ |
| K991587 | BLOM-SINGER INDWELLING 2000 VOICE PROSTHESIS | Helix Medical, Inc. | 1999-06-25 | Traditional | PDF ↗ |
| K974132 | VOICE MASTER PROSTHESIS | E. Benson Hood Lab, Inc. | 1998-02-25 | Traditional | PDF ↗ |
| K971244 | PROVOX 2 VOICE PROSTHESIS SYSTEM | Atos Medical AB | 1997-06-06 | Traditional | PDF ↗ |
| K945287 | INHEALTH BLOM-SINGER INDWELLING VALVED INSERT ACCESSORY DEVICE | Helix Medical, Inc. | 1994-12-09 | Traditional | PDF ↗ |
| K945288 | INHEALTH BLOM-SINGER INDWELLING PLUG INSERT ACCESSORY DEVICE | Helix Medical, Inc. | 1994-12-02 | Traditional | PDF ↗ |
| K940638 | PROVOX(TM) VOICE PROSTHESIS | Atos Medical AB | 1994-06-22 | Traditional | PDF ↗ |
| K932120 | BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES | Helix Medical, Inc. | 1994-04-15 | Traditional | PDF ↗ |
| K932163 | BLOM-SINGER VOICE PROSTHESIS FLUSHING PIPET | Helix Medical, Inc. | 1993-12-15 | Traditional | PDF ↗ |
| K930105 | BLOM-SINGER LOW PRESSURE VOICE PROSTHESIS,P.I.D.S. | Helix Medical, Inc. | 1993-05-17 | Traditional | PDF ↗ |
| K920090 | BLOM-SINGER TRACHEOESOPHAGEAL PUNCTURE SET | Helix Medical, Inc. | 1992-09-10 | Traditional | PDF ↗ |
| K912486 | SINGH SPEECH SYSTEM (SERIES 'SSS') | Exmoor Plastics , Ltd. | 1992-09-04 | Traditional | PDF ↗ |
| K915761 | BIVONA-COLORADO VOICE PROSTHESIS | Bivona Medical Technologies | 1992-06-29 | Traditional | PDF ↗ |
| K904729 | BLOM-SINGER SHOWER GUARD | Helix Medical, Inc. | 1991-02-28 | Traditional | PDF ↗ |
| K902112 | BLOM-SINGER(R) TRACHEOESOPHAGEAL FISTULA STENT | Helix Medical, Inc. | 1990-08-01 | Traditional | PDF ↗ |
| K900518 | BLOM-SINGER(R) TRACHEOESOPHAGEAL PUNCTURE KIT | Helix Medical, Inc. | 1990-06-14 | Traditional | PDF ↗ |
| K881011 | BIVONA ULTRA LOW RESISTANCE VOICE PROSTHESIS | Bivona Medical Technologies | 1988-05-13 | Traditional | PDF ↗ |
| K871885 | ESKA-HERRMANN TRACHEOSTOMY VALVE | C.R. Bard, Inc. | 1987-06-08 | Traditional | PDF ↗ |
| K861088 | BIVONA ECONOMY DUCKBILL VOICE PROSTHESIS | Bivona Medical Technologies | 1986-04-02 | Traditional | PDF ↗ |
| K854118 | DACOMED CORP. ESKA-HERRMAN VOICE PROSTHESIS | Dacomed Corp. | 1986-03-17 | Traditional | PDF ↗ |
| K854112 | FLEXIBLE GRASPING FORCEPS | Hood Laboratories | 1986-03-12 | Traditional | PDF ↗ |
| K853940 | THE GRONINGEN VOICE PROSTHESIS | Hood Laboratories | 1985-12-13 | Traditional | PDF ↗ |
| K842896 | BLOM-SINGER LOW PRESSURE VOICE PROSTHES | American V. Mueller | 1984-08-17 | Traditional | PDF ↗ |
| K832967 | DUCKBILL VOICE PROSTHESIS & TRACHEO | American V. Mueller | 1983-12-23 | Traditional | PDF ↗ |
| K832852 | BLAISE-RATHAEL VOICE PROSTHESIS | Richards Medical Co., Inc. | 1983-09-29 | Traditional | PDF ↗ |
| K823749 | LOW PRESSURE BLOM-SINGER VOICE PROSTHES | Bivona Medical Technologies | 1983-01-07 | Traditional | PDF ↗ |
| K821568 | BLOW-SINGER TRACHEOSTOMA VALVE | Bivona Medical Technologies | 1982-07-26 | Traditional | PDF ↗ |
| K820737 | PERISCOPE VOICE PROSTHESIS | Bivona Medical Technologies | 1982-04-09 | Traditional | PDF ↗ |
| K812982 | BLOM-SINGER VOICE PROSTHESIS | Bivona Medical Technologies | 1981-11-24 | Traditional | PDF ↗ |
| K812864 | SILASTIC VOICE PROSTHESIS | Dow Corning Corp. Healthcare Industries Materials | 1981-11-24 | Traditional | PDF ↗ |
| K810020 | PANJE VOICE PROSTHESIS | Xomed, Inc. | 1981-02-05 | Traditional | PDF ↗ |
| K800563 | BLOM-SINGER DUCKBILL VOICE PROSTHESIS | Bivona Medical Technologies | 1980-03-25 | Traditional | PDF ↗ |
Product code EWL · Class II · Ear, Nose, Throat. Data: openFDA.