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 7 of 14
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K911182 | NNHS 2050 SERIES (2055W-2054PP) HEARING AIDS | Magnatone Hearing Aid Corp. | 1991-05-09 | Traditional | PDF ↗ |
| K911174 | NHS 2009SP HEARING AID | Magnatone Hearing Aid Corp. | 1991-05-09 | Traditional | PDF ↗ |
| K911579 | STARKEY TRILOGY PROGRAM HEAR AID CC/CE MODELS | Starkey Laboratories, Inc. | 1991-05-07 | Traditional | PDF ↗ |
| K911497 | CUSTOM PERSONAL EAR - CPE | Qualitone | 1991-04-19 | Traditional | PDF ↗ |
| K911498 | ADJUSTRETTE - DAO, MODIFICATION | Qualitone | 1991-04-19 | Traditional | PDF ↗ |
| K911504 | ULTRA & ULTRA LITE II, MODIFICATION | Qualitone | 1991-04-19 | Traditional | PDF ↗ |
| K911499 | ELEGANCE - DEO, MODIFICATION | Qualitone | 1991-04-19 | Traditional | PDF ↗ |
| K911210 | PHONAK 9800 SC-AF ITE HEARING INSTRUMENT | Phonak, Inc. | 1991-04-17 | Traditional | PDF ↗ |
| K911211 | PHONAK 9100 SC-AF ITE HEARING INSTRUMENT | Phonak, Inc. | 1991-04-17 | Traditional | PDF ↗ |
| K910325 | AHL, ITE MODEL AMERICAN | Bob Bare Hearing Aid Repair | 1991-04-15 | Traditional | PDF ↗ |
| K911209 | PHONAK 9300 SC-AF ITE HEARING INSTRUMENT | Phonak, Inc. | 1991-04-15 | Traditional | PDF ↗ |
| K905516 | MODEL FT40 TRANSONIC(TM) HEARING AID | Sonovation, Inc. Dba Avr Sonovation | 1991-04-09 | Traditional | PDF ↗ |
| K905740 | RESORBABLE BONE PLUG | Zimmer, Inc. | 1991-04-03 | Traditional | PDF ↗ |
| K910097 | ELECTONE ITE MODEL PREMIER | Electone, Inc. | 1991-04-03 | Traditional | PDF ↗ |
| K911064 | DAHLBERG MODEL LG BTE HEARING AID | Miracle-Ear, Inc. | 1991-03-21 | Traditional | PDF ↗ |
| K910979 | DAHLBERG MODEL LT BTE HEARING AID | Miracle-Ear, Inc. | 1991-03-21 | Traditional | PDF ↗ |
| K910809 | DAHLBERG MODEL LB BEHIND-THE-EAR HEARING AID | Miracle-Ear, Inc. | 1991-03-21 | Traditional | PDF ↗ |
| K911063 | DAHLBERG MODEL LU BTE HEARING AID | Miracle-Ear, Inc. | 1991-03-21 | Traditional | PDF ↗ |
| K911096 | DAHLBERG MODEL LZ BTE HEARING AID | Miracle-Ear, Inc. | 1991-03-21 | Traditional | PDF ↗ |
| K910312 | C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID | Ototech, Ltd. | 1991-03-18 | Traditional | PDF ↗ |
| K905784 | CUSTOM ITE HEARING AID | Hearing Aid Co. | 1991-03-18 | Traditional | PDF ↗ |
| K910314 | C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID | Ototech, Ltd. | 1991-03-18 | Traditional | PDF ↗ |
| K910313 | ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID | Ototech, Ltd. | 1991-03-18 | Traditional | PDF ↗ |
| K910311 | ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID | Ototech, Ltd. | 1991-03-18 | Traditional | PDF ↗ |
| K905371 | ITE HEARING AID | Audicare Hearing Center | 1991-03-15 | Traditional | PDF ↗ |
| K904756 | MATRICS | Kerr Corporation (Danbury) | 1991-03-15 | Traditional | PDF ↗ |
| K910690 | 3M MODEL 8240 ITE HEARING AID | 3M Company | 1991-03-13 | Traditional | PDF ↗ |
| K910028 | POST AURICULAR HEARING AID MODEL PICO SC-H | Phonak, Inc. | 1991-03-08 | Traditional | PDF ↗ |
| K905680 | 543 SERIES BTE | Hearing Tech, Inc. | 1991-03-08 | Traditional | PDF ↗ |
| K910763 | 3M MODEL 8245 ITE HEARING AID | 3M Company | 1991-02-28 | Traditional | PDF ↗ |
| K910743 | PHILIPS MODEL S46-OL BTE HEARING AID | Philips Hearing Instruments Co. | 1991-02-28 | Traditional | PDF ↗ |
| K910705 | ACTIVE MODEL AHX HELIX ITE HEARING AID | Active Electronics, Inc. | 1991-02-28 | Traditional | PDF ↗ |
| K910703 | ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AID | Active Electronics, Inc. | 1991-02-28 | Traditional | PDF ↗ |
| K910701 | ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID | Active Electronics, Inc. | 1991-02-28 | Traditional | PDF ↗ |
| K910704 | ACTIVE MODEL AMC MINI CANAL ITE HEARING AID | Active Electronics, Inc. | 1991-02-28 | Traditional | PDF ↗ |
| K910761 | 3M MODEL 8243 ITE HEARING AID | 3M Company | 1991-02-28 | Traditional | PDF ↗ |
| K910744 | PHILIPS MODEL S46-O BTE HEARING AID | Philips Hearing Instruments Co. | 1991-02-28 | Traditional | PDF ↗ |
| K910012 | PHONAK MODEL PICO C-S-H-T, BTE HEARING AID | Phonak, Inc. | 1991-02-28 | Traditional | PDF ↗ |
| K910018 | POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC | Phonak, Inc. | 1991-02-28 | Traditional | PDF ↗ |
| K910700 | ACTIVE MODEL AST CUSTOM ITE HEARING AID | Active Electronics, Inc. | 1991-02-28 | Traditional | PDF ↗ |
| K910762 | 3M MODEL 8244 ITE HEARING AID | 3M Company | 1991-02-28 | Traditional | PDF ↗ |
| K910759 | 3M MODEL 8241 ITE HEARING AID | 3M Company | 1991-02-28 | Traditional | PDF ↗ |
| K910702 | ACTIVE MODEL AHS HALF SHELL ITE HEARING AID | Active Electronics, Inc. | 1991-02-28 | Traditional | PDF ↗ |
| K910760 | 3M MODEL 8242 ITE HEARING AID | 3M Company | 1991-02-28 | Traditional | PDF ↗ |
| K910206 | PHILIPS MODEL S47 BTE HEARING AID | Philips Hearing Instruments Co. | 1991-02-05 | Traditional | PDF ↗ |
| K910102 | ELECTONE BTE MODEL AM 240 PPL | Electone, Inc. | 1991-01-29 | Traditional | PDF ↗ |
| K910100 | ELECTONE BTE MODEL AM 130 D | Electone, Inc. | 1991-01-29 | Traditional | PDF ↗ |
| K910101 | ELECTONE BTE MODEL AM 130 PP | Electone, Inc. | 1991-01-29 | Traditional | PDF ↗ |
| K910099 | ELECTONE BTE MODEL AM 240 HF | Electone, Inc. | 1991-01-29 | Traditional | PDF ↗ |
| K910148 | AM130 AGC-O (BEHIND THE EAR) HEARING AID | Electone, Inc. | 1991-01-29 | Traditional | PDF ↗ |
| K910096 | ELECTONE BTE MODEL AM900 PP | Electone, Inc. | 1991-01-29 | Traditional | PDF ↗ |
| K910103 | ELECTONE BTE MODEL AM 130 HF | Electone, Inc. | 1991-01-29 | Traditional | PDF ↗ |
| K905679 | 133 SERIES BTE | Gn Danavox, Inc. | 1991-01-28 | Traditional | PDF ↗ |
| K910098 | ELECTONE BTE MODEL AM 240 PPI | Electone, Inc. | 1991-01-28 | Traditional | PDF ↗ |
| K905692 | 143 SERIES BTE | Gn Danavox, Inc. | 1991-01-28 | Traditional | PDF ↗ |
| K905483 | MEMORYMATE MODEL 8270 ITE HEARING AID | 3M Company | 1990-12-28 | Traditional | PDF ↗ |
| K903145 | HEARSET TELEPHONE HEARING SYSTEM | Starkey Laboratories, Inc. | 1990-12-21 | Traditional | PDF ↗ |
| K904020 | MEMORYMATE HEARING AID WITH PMC PROGRAMMER | 3M Company | 1990-12-17 | Traditional | PDF ↗ |
| K904731 | QUALITONE ITE GENESIS | Qualitone | 1990-12-17 | Traditional | PDF ↗ |
| K904730 | QUALITONE ULTRA CANAL GENESIS | Qualitone | 1990-12-07 | Traditional | PDF ↗ |
| K904576 | HEARING AID, UNITRON MODEL UM60-UH | Unitron Industries, Inc. | 1990-12-07 | Traditional | PDF ↗ |
| K903471 | BEST LABS MODEL P | Best Labs | 1990-11-09 | Traditional | PDF ↗ |
| K903472 | BEST LABS MODEL M | Best Labs | 1990-11-09 | Traditional | PDF ↗ |
| K903473 | BEST LABS MODEL S | Best Labs | 1990-11-09 | Traditional | PDF ↗ |
| K903474 | BEST LABS MODEL C | Best Labs | 1990-11-09 | Traditional | PDF ↗ |
| K904673 | OTICAON BTE MODEL E34P | Oticon Corp. | 1990-11-01 | Traditional | PDF ↗ |
| K902846 | PRIZM HEARING SYSTEM | Audioscience, Inc. | 1990-10-31 | Traditional | PDF ↗ |
| K902487 | MODIFIED HEARING AID (IN-THE-EAR) | Audio Hearing Aid Service | 1990-10-09 | Traditional | PDF ↗ |
| K903583 | SERIES MCAXX (MODEL 851) ITE HEARING AID | Maico Hearing Instruments, Inc. | 1990-10-09 | Traditional | PDF ↗ |
| K903860 | ITE HEARING AID, SAAPHIRE MODEL | Improved Hearing Service, Inc. | 1990-10-09 | Traditional | PDF ↗ |
| K903415 | ITE HEARING AID, SOUND MED EMERALD MODEL | Improved Hearing Service, Inc. | 1990-10-09 | Traditional | PDF ↗ |
| K903864 | ITE HEARING AID, PEARL MODEL | Improved Hearing Service, Inc. | 1990-10-09 | Traditional | PDF ↗ |
| K903859 | ITE HEARING AID, DIAMOND MODEL | Improved Hearing Service, Inc. | 1990-10-09 | Traditional | PDF ↗ |
| K903861 | ITE HEARING AID, SOUND MED GOLDEN NUGGET MODEL | Improved Hearing Service, Inc. | 1990-10-09 | Traditional | PDF ↗ |
| K903478 | AUDIOTECH MODEL CL | Muskogee Regional Hearing Aid Lab | 1990-10-09 | Traditional | PDF ↗ |
| K903865 | ITE HEARING AID, SOUND MED AMETHYST MODEL | Improved Hearing Service, Inc. | 1990-10-09 | Traditional | PDF ↗ |
| K903863 | ITE HEARING AID, SOUND MED OPAL MODEL | Improved Hearing Service, Inc. | 1990-10-09 | Traditional | PDF ↗ |
| K903862 | ITE HEARING AID, SOUND MED RUBY MODEL | Improved Hearing Service, Inc. | 1990-10-09 | Traditional | PDF ↗ |
| K903479 | AUDIOTECH MODEL DB | Muskogee Regional Hearing Aid Lab | 1990-10-09 | Traditional | PDF ↗ |
| K903760 | MODEL TRITON 3000 BTE HEARING AID AND PMC SYSTEM | Siemens Hearing Instruments, Inc. | 1990-10-05 | Traditional | PDF ↗ |
| K900632 | DYNASTY HEARING SYSTEMS INSTRUMENT | Alastair Granville-Jackson, Mfa, Ed.D. | 1990-09-12 | Traditional | PDF ↗ |
| K903295 | ESCORT ITC | Hearing Tech, Inc. | 1990-09-05 | Traditional | PDF ↗ |
| K902179 | VISTA - MODELS V12, V20, V23, V38, ITE HEARING AID | Vista Laboratories, Inc. | 1990-08-10 | Traditional | PDF ↗ |
| K901833 | CE-8 CUSTOM IN-THE-EAR HEARING AIDS | Starkey Laboratories, Inc. | 1990-08-09 | Traditional | PDF ↗ |
| K902290 | ITE HEARING AID MODEL PALOMINO | Improved Hearing Service, Inc. | 1990-08-01 | Traditional | PDF ↗ |
| K903023 | HERITAGE III (HTC) ITC TYPE HEARING AID | Hearing Tech, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K901341 | REXTON RX12 POWER PLUS W/DUAL RECEIVER | Rexton, Inc. | 1990-07-27 | Traditional | PDF ↗ |
| K901860 | INTRA III AND INTRA IV HEARING AIDS | Starkey Laboratories, Inc. | 1990-07-20 | Traditional | PDF ↗ |
| K902570 | ADAM MARK II CUSTOM IN-THE-EAR HEARING AID | Adams Hearing Aid Center | 1990-07-09 | Traditional | PDF ↗ |
| K902559 | CUSTOM IN-THE-EAR HEARING AID OTICON MODEL: P | Oticon Corp. | 1990-07-09 | Traditional | PDF ↗ |
| K902351 | CUSTOM ITE HEARING AID MODELS C AND M | Oticon Corp. | 1990-06-14 | Traditional | PDF ↗ |
| K902353 | CUSTOM ITE HEARING AID MODELS F AND L | Oticon Corp. | 1990-06-14 | Traditional | PDF ↗ |
| K902352 | CUSTOM ITE HEARING AID MODEL: H | Oticon Corp. | 1990-06-14 | Traditional | PDF ↗ |
| K901783 | AUDIOTONE ITE HEARING AID MODEL ZA (MICRO) | Miracle-Ear, Inc. | 1990-05-29 | Traditional | PDF ↗ |
| K901746 | AUDIOTONE ITE HEARING AID MODEL ZD (XT) | Miracle-Ear, Inc. | 1990-05-29 | Traditional | PDF ↗ |
| K901745 | AUDIOTONE MODEL A-52S BEHIND-THE-EAR HEARING INST. | Miracle-Ear, Inc. | 1990-05-29 | Traditional | PDF ↗ |
| K901747 | AUDIOTONE ITE HEARING AID MODEL ZG (MIRAGE) | Miracle-Ear, Inc. | 1990-05-29 | Traditional | PDF ↗ |
| K897035 | MIRACLE EAR MODEL PC PROG. IN-THE-EAR HEARING AID | Miracle-Ear, Inc. | 1990-05-23 | Traditional | PDF ↗ |
| K900829 | BTE SUPER-FRONT PPSCL, SUPER-FRONT PPSC | Phonak, Inc. | 1990-05-23 | Traditional | PDF ↗ |
| K897033 | WIDEX BTE HEARING AID MODEL Q16 WITH REMOTE | Widex Hearing Aid Co., Inc. | 1990-05-23 | Traditional | PDF ↗ |
Product code ESD · Class I · Ear, Nose, Throat. Data: openFDA.