FDA Product Code
FDA Product Code ESD — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Ear, Nose, Throat
- 21 CFR Citation
- 874.3300
510(k) Clearances — 1,367 records · page 4 of 14
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K944548 | REXPLUS PP3 | Rexton, Inc. | 1994-11-14 | Traditional | PDF ↗ |
| K944078 | PROGRAM 3-CH SER HEAR AIDS W/PROGRAM FIT SYST/PRO FIT | Argosy Electronics | 1994-10-21 | Traditional | PDF ↗ |
| K943687 | FEDELITY F495, VIENNATONE ALPP II | Starkey Laboratories, Inc. | 1994-10-20 | Traditional | PDF ↗ |
| K943960 | UV CURED METHYL METHACRYLATE HEARING AID SHELL MATERIALS | Miracle-Ear, Inc. | 1994-10-20 | Traditional | PDF ↗ |
| K944838 | WIDEX MODEL LX-ITE | Widex Hearing Aid Co., Inc. | 1994-10-20 | Traditional | PDF ↗ |
| K944502 | BELTONE CONCERTO S | Beltone Electronics Corp. | 1994-10-20 | Traditional | PDF ↗ |
| K944077 | PROGRAM 3-CH SERIES HEAR AIDS W/DT-1 DESKTOP PROGRAM | Argosy Electronics | 1994-10-12 | Traditional | PDF ↗ |
| K943826 | MIRACLE-EAR MIRAGE | Miracle-Ear, Inc. | 1994-09-23 | Traditional | PDF ↗ |
| K942523 | MIRACLE-EAR IMPRESSION MATERIAL KIT | Miracle-Ear, Inc. | 1994-09-23 | Traditional | PDF ↗ |
| K943825 | MIRACLE EAR CONFIDANTE | Miracle-Ear, Inc. | 1994-09-21 | Traditional | PDF ↗ |
| K943788 | RESOUND PERSONAL HEARING SYSTEM | Resound Corp. | 1994-09-21 | Traditional | PDF ↗ |
| K943318 | ALL-IN-THE-EAR | Golden State Audiology Assoc. | 1994-09-16 | Traditional | PDF ↗ |
| K934752 | SIEMENS MODEL 584 P-2 | Siemens Hearing Instruments, Inc. | 1994-09-07 | Traditional | PDF ↗ |
| K935019 | INFINITY 252 | Siemens Hearing Instruments, Inc. | 1994-09-07 | Traditional | PDF ↗ |
| K942857 | SIEMENS BTE HEARING AIDS | Siemens Hearing Instruments, Inc. | 1994-08-22 | Traditional | PDF ↗ |
| K943706 | AUDILENS LLK | Widex Hearing Aid Co., Inc. | 1994-08-22 | Traditional | PDF ↗ |
| K943670 | MO6 SERIES | Philips Hearing Instruments Co. | 1994-08-18 | Traditional | PDF ↗ |
| K943682 | SM-VEGA, SM-PC, SM-AGC, SM-AGC-H | Starkey Laboratories, Inc. | 1994-08-17 | Traditional | PDF ↗ |
| K942895 | MIRACLE EAR MODEL PGM | Miracle-Ear/Dahlberg, Inc. | 1994-08-17 | Traditional | PDF ↗ |
| K942894 | MIRACLE-EAR MODEL PGC | Miracle-Ear/Dahlberg, Inc. | 1994-08-17 | Traditional | PDF ↗ |
| K942893 | MIRACLE-EAR MODEL PGF + REMOTE | Miracle-Ear/Dahlberg, Inc. | 1994-08-17 | Traditional | PDF ↗ |
| K943395 | PHILIPS M38 SERIES | Philips Hearing Instruments Co. | 1994-08-09 | Traditional | PDF ↗ |
| K940667 | STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID | Starkey Laboratories, Inc. | 1994-08-09 | Traditional | PDF ↗ |
| K941107 | THE CANAL (C.I.C.) AKA/HIDDEN EAR | Qualitone, Inc. | 1994-08-09 | Traditional | PDF ↗ |
| K942189 | CRYSTAL EAR | Crystal Care Intl., Inc. | 1994-08-09 | Traditional | PDF ↗ |
| K940670 | EARCRAFT HEARING AID | Earcraft, Inc. | 1994-08-04 | Traditional | PDF ↗ |
| K941859 | MIRACLE-EAR EAR IMPRESSION MATERIAL | Miracle-Ear/Dahlberg, Inc. | 1994-07-25 | Traditional | PDF ↗ |
| K942831 | HAE 2 | Hearing Aid Express | 1994-07-20 | Traditional | PDF ↗ |
| K942829 | HAE 1 | Hearing Aid Express | 1994-07-20 | Traditional | PDF ↗ |
| K943144 | AURIS CIC | General Hearing Instruments, Inc. | 1994-07-20 | Traditional | PDF ↗ |
| K942830 | HAE 3 | Hearing Aid Express | 1994-07-20 | Traditional | PDF ↗ |
| K942749 | HI-PRO/NOAH UNIVERSAL HEARING INSTRUMENT | Madsen Electronics (Canada) , Ltd. | 1994-07-18 | Traditional | PDF ↗ |
| K942594 | STAR 42 PP SP STAR 42 DIGITALLY PROGRAMMABLE HEARING AID | Starkey Laboratories, Inc. | 1994-07-05 | Traditional | PDF ↗ |
| K940164 | SUPER-SIL | Finetone Hearing Instruments | 1994-06-29 | Traditional | PDF ↗ |
| K941587 | HEARING TECH | Hearing Tech, Inc. | 1994-06-24 | Traditional | PDF ↗ |
| K942036 | EUROSTAR SUPER, EUROSTAR VFC | Starkey Laboratories, Inc. | 1994-06-24 | Traditional | PDF ↗ |
| K941295 | SHARP II HELIX HEARING AID | Miracle-Ear, Inc. | 1994-06-17 | Traditional | PDF ↗ |
| K942213 | OPTIMA WITH DELTA AMP | Beltone Electronics Corp. | 1994-06-17 | Traditional | PDF ↗ |
| K942164 | PHILIPS 61 SERIES | Philips Hearing Instruments Co. | 1994-06-17 | Traditional | PDF ↗ |
| K940098 | BELTONE INVISA | Beltone Electronics Corp. | 1994-06-15 | Traditional | PDF ↗ |
| K941734 | PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS | Phonak, Inc. | 1994-05-13 | Traditional | PDF ↗ |
| K932269 | PRO-CONNECT | Starkey Laboratories, Inc. | 1994-05-13 | Traditional | PDF ↗ |
| K941133 | 770-ATC | Electone, Inc. | 1994-05-12 | Traditional | PDF ↗ |
| K941293 | SHARP II SEMI CONTOUR HEARING AID | Miracle-Ear, Inc. | 1994-05-12 | Traditional | PDF ↗ |
| K941121 | AUDIOTONE MODEL A-54 | Miracle-Ear, Inc. | 1994-05-12 | Traditional | PDF ↗ |
| K941039 | WAX GUARD OPTION | Miracle-Ear, Inc. | 1994-05-12 | Traditional | PDF ↗ |
| K941292 | SHARP II FULL CONTOUR | Miracle-Ear, Inc. | 1994-05-12 | Traditional | PDF ↗ |
| K941294 | SHARP II LOW PROFILE HEARING AID | Miracle-Ear, Inc. | 1994-05-12 | Traditional | PDF ↗ |
| K941122 | AUDIOTONE MODEL A-54SR | Miracle-Ear, Inc. | 1994-05-12 | Traditional | PDF ↗ |
| K941395 | BELTON MERIT (HEARING AID) | Beltone Electronics Corp. | 1994-05-04 | Traditional | PDF ↗ |
| K941636 | MINI PAK | Starkey Laboratories, Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K941140 | RIONET HEARING AID HB-37T | Authorized Hearing Systems, Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K941508 | WIDEX S-21 | Widex Hearing Aid Co., Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K940608 | 155 PP AGC-I | Danavox, Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K941635 | INTRA S, INTRA SH | Starkey Laboratories, Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K941021 | RIONET HEARING AID HB-54 | Authorized Hearing Systems, Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K935962 | MIRACLE-EAR WITH POWER CIRCUIT OPTION | Miracle-Ear, Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K940978 | STARKEY EUROLINE A SERIES | Starkey Laboratories, Inc. | 1994-05-04 | Traditional | PDF ↗ |
| K940116 | COMPLETELY IN THE CANAL | Argosy Electronics | 1994-05-03 | Traditional | PDF ↗ |
| K936190 | BEHIND THE EAR HEARING AID | Audina Hearing Instrument | 1994-04-04 | Traditional | PDF ↗ |
| K940102 | BELTONE OPERA/OPERA MHP/OPERA MAX | Beltone Electronics Corp. | 1994-04-01 | Traditional | PDF ↗ |
| K940101 | OTOSONIC ACS II D WITH SRR | Beltone Electronics Corp. | 1994-04-01 | Traditional | PDF ↗ |
| K940099 | OTOSONIC (OSI) LPS D; LPS D IC; LPS D ASP | Beltone Electronics Corp. | 1994-04-01 | Traditional | PDF ↗ |
| K940103 | BELTONE ODE AND BELTONE ODE VX; ODE CLEARVOICE IC AND BELTONE ODE VX CLEARVOICE IC; BELTONE ODE CLEARVOICE ANF AND | Beltone Electronics Corp. | 1994-04-01 | Traditional | PDF ↗ |
| K940177 | OTOSONIC CF-2, CF-2 IC, CF-2 ANF, CF-2 WITH IMPROVED CLASS D (DELTA AMP) | Beltone Electronics Corp. | 1994-04-01 | Traditional | PDF ↗ |
| K940100 | PROFILE IC; PROFILE CLEARVOICE; PROFILE | Beltone Electronics Corp. | 1994-04-01 | Traditional | PDF ↗ |
| K940639 | LORI-CIC HEARING AID | Lori Medical Laboratories, Inc. | 1994-03-25 | Traditional | PDF ↗ |
| K940104 | OTOSONIC MINI PAS | Beltone Electronics Corp. | 1994-03-24 | Traditional | PDF ↗ |
| K935867 | AIR CONDUCTION HEARING AID, UNITRON IKON K & KD | Unitron Industries, Inc. | 1994-03-22 | Traditional | PDF ↗ |
| K940458 | MIRACLE-EAR CONFIDANTE | Miracle-Ear, Inc. | 1994-03-21 | Traditional | PDF ↗ |
| K936106 | AIR CONDUCTION HEARING AID: IKON PP | Unitron Industries, Inc. | 1994-03-21 | Traditional | PDF ↗ |
| K936122 | RIONET HEARING AID HB-53CI | Authorized Hearing Systems, Inc. | 1994-03-21 | Traditional | PDF ↗ |
| K935424 | WIDEX R.C. 2 (REMOTE CONTROL) | Widex Hearing Aid Co., Inc. | 1994-03-17 | Traditional | PDF ↗ |
| K934940 | MIRACLE-EAR ENTRE | Miracle-Ear, Inc. | 1994-03-07 | Traditional | PDF ↗ |
| K936007 | PRIZM HEARING SYSTEM, MODEL POWER BTE | Audioscience, Inc. | 1994-03-04 | Traditional | PDF ↗ |
| K935559 | HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000 | Rockwin Corp. | 1994-01-27 | Traditional | PDF ↗ |
| K935791 | PHONAK PICONET 232X-AZ BTE HEARING INSTRUMENT | Phonak, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K935330 | NU.EAR SS-3 IN THE CANAL (ITC) HEARING AID | Nu-Ear Electronics | 1994-01-21 | Traditional | PDF ↗ |
| K935326 | NU-EAR SD-10 IN THE CANAL HEARING AID | Nu-Ear Electronics | 1994-01-21 | Traditional | PDF ↗ |
| K935328 | NU.EAR SS-2 IN THE CANAL (ITC) HEARING AID | Nu-Ear Electronics | 1994-01-21 | Traditional | PDF ↗ |
| K935331 | NU.EAR SD-3 IN THE CANAL (ITC) HEARING AID | Nu-Ear Electronics | 1994-01-21 | Traditional | PDF ↗ |
| K935327 | NU.EAR SD-2 IN-THE-CANAL (ITC) HEARING AID | Nu-Ear Electronics | 1994-01-21 | Traditional | PDF ↗ |
| K935335 | NU.EAR SS-10 IN THE CANAL (ITC) HEARING AID | Nu-Ear Electronics | 1994-01-21 | Traditional | PDF ↗ |
| K935329 | NU.EAR AE-2 IN THE CANAL (ITC) HEARING AID | Nu-Ear Electronics | 1994-01-21 | Traditional | PDF ↗ |
| K935334 | NU.EAR SD-1 IN THE EAR (ITE) HEARING AID | Nu-Ear Electronics | 1994-01-21 | Traditional | PDF ↗ |
| K935332 | NU.EAR AE-1 IN THE EAR (ITE) HEARING AID | Nu-Ear Electronics | 1994-01-21 | Traditional | PDF ↗ |
| K935333 | NU.EAR SS-1 IN THE EAR (ITE) HEARING AID | Nu-Ear Electronics | 1994-01-21 | Traditional | PDF ↗ |
| K935366 | BINAURAL HEARING AID | Telex Communications, Inc. | 1994-01-13 | Traditional | PDF ↗ |
| K935458 | AUDIPHON, MODEL H-11 | National Hearing Aid Dist., Inc. | 1994-01-05 | Traditional | PDF ↗ |
| K934149 | MICRO-TECH TRU CANAL | Micro-Ear Technology, Inc. | 1993-12-27 | Traditional | PDF ↗ |
| K935289 | PRO FIT-CYBER II OPTION | Qualitone | 1993-12-22 | Traditional | PDF ↗ |
| K935095 | 8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS | 3M Company | 1993-12-15 | Traditional | PDF ↗ |
| K933963 | PAL (PERSONAL AMPLIFIER FOR LISTENING) | Hearing Care Products, Inc. | 1993-12-15 | Traditional | PDF ↗ |
| K935265 | MIRACLE EAR MODEL SHARP II CANAL | Miracle-Ear, Inc. | 1993-12-15 | Traditional | PDF ↗ |
| K935266 | MIRACLE EAR MODEL SHARP II MICRO CANAL HEARING AID | Miracle-Ear, Inc. | 1993-12-15 | Traditional | PDF ↗ |
| K935420 | SOUNDRIGHT, SHP | Soundright Hearing Products | 1993-12-15 | Traditional | PDF ↗ |
| K934565 | UNITRON MODEL IKON AGCO/ AOD | Unitron Industries, Inc. | 1993-11-29 | Traditional | PDF ↗ |
| K934417 | OMNI 2000 SERIES ITC HEARING AID | Starkey Laboratories, Inc. | 1993-11-29 | Traditional | PDF ↗ |
| K934416 | OMNI 2000 SERIES ITE HEARING AID | Starkey Laboratories, Inc. | 1993-11-29 | Traditional | PDF ↗ |
| K934479 | RIONET HEARING AID HA-72 | Authorized Hearing Systems, Inc. | 1993-11-19 | Traditional | PDF ↗ |
Product code ESD · Class I · Ear, Nose, Throat. Data: openFDA.