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 10 of 14
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K870723 | HEARTECH HFX, HEARING AID | Hearing Tech, Inc. | 1987-03-20 | Traditional | PDF ↗ |
| K870691 | DAHLBERG MODEL UV TRIMLINE IN-THE-EAR HEARING AID | Dahlberg Electronics, Inc. | 1987-03-13 | Traditional | PDF ↗ |
| K870503 | HEARING AID, UNITRON MODEL UM60 | Unitron Industries, Inc. | 1987-03-11 | Traditional | PDF ↗ |
| K870435 | MODEL 350 WIRELESS CROS/CROS LOW OUTPUT HEAR. AID | Telex Communications, Inc. | 1987-03-11 | Traditional | PDF ↗ |
| K870350 | ESCORT EC CUSTOM IN-THE-EAR HEARING AID | Hearing Tech, Inc. | 1987-03-11 | Traditional | PDF ↗ |
| K870434 | MODEL 350 WIRELESS BICROS/MULTICROS HEARING AIDS | Telex Communications, Inc. | 1987-03-11 | Traditional | PDF ↗ |
| K870080 | MICRO-EAR FULL-CONCHA IN-THE-EAR HEARING AID | Micro-Ear Hearing Center, Inc. | 1987-03-03 | Traditional | PDF ↗ |
| K870079 | MICRO-EAR CANAL IN-THE-EAR HEARING AID | Micro-Ear Hearing Center, Inc. | 1987-03-03 | Traditional | PDF ↗ |
| K870081 | MICRO-EAR LOW-PROFILE IN-THE-EAR HEARING AID | Micro-Ear Hearing Center, Inc. | 1987-03-03 | Traditional | PDF ↗ |
| K864672 | PHONIC EAR MODELS PE 811CS AND PE 811CST | Phonic Ear, Inc. | 1987-02-20 | Traditional | PDF ↗ |
| K864277 | UNIMAX ITE & ULTRAMAX-CCR CUSTOM CANAL INSTRUMENTS | Unimax Hearing Instruments | 1987-01-09 | Traditional | PDF ↗ |
| K864823 | BEHIND THE EAR HEARING AIDS, BERNAFON COLIBRI, C1 | Bernafon, Inc. | 1987-01-06 | Traditional | PDF ↗ |
| K864028 | MODEL AQ8181 CUSTOM-CANAL-IN-THE EAR HEARING AID | Int'L Hearing Aids, Inc. | 1986-11-13 | Traditional | PDF ↗ |
| K864029 | AY8182 CUSTOM-SEMI CANAL-IN-THE-EAR HEARING AID | Int'L Hearing Aids, Inc. | 1986-11-13 | Traditional | PDF ↗ |
| K864030 | MODEL AJ8183 CUSTOM-IN-THE-EAR HEARING AID | Int'L Hearing Aids, Inc. | 1986-11-13 | Traditional | PDF ↗ |
| K864031 | MODEL AK 8184 CUSTOM-LOW-PROFILE HEARING AID | Int'L Hearing Aids, Inc. | 1986-11-13 | Traditional | PDF ↗ |
| K863975 | CUSTOM IN-THE-EAR | Gn Danavox, Inc. | 1986-11-07 | Traditional | PDF ↗ |
| K864097 | WIDEX HEARING AID MODEL ES2 | Widex Hearing Aid Co., Inc. | 1986-11-05 | Traditional | PDF ↗ |
| K864180 | INTEGRA, CUSTOM IN-THE-EAR HEARING AID | Bernafon, Inc. | 1986-11-05 | Traditional | PDF ↗ |
| K863225 | UNITRON MODEL UL21 HEARING AID | Unitron Industries, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K862981 | OTICON I31 INITIALES HEARING AID | Oticon Corp. | 1986-10-15 | Traditional | PDF ↗ |
| K863787 | PA EQUALIZER | Electone, Inc. | 1986-10-14 | Traditional | PDF ↗ |
| K862980 | OTICON I31 CITE HEARING AID | Oticon Corp. | 1986-08-26 | Traditional | PDF ↗ |
| K862623 | I81 INITIALES | Oticon Corp. | 1986-08-07 | Traditional | PDF ↗ |
| K862622 | I22 CITE | Oticon Corp. | 1986-08-01 | Traditional | PDF ↗ |
| K862754 | CUSTOM IN-THE-EAR AND CANAL HEARING AID | Cochlear Laboratories, Ltd. | 1986-08-01 | Traditional | PDF ↗ |
| K862760 | HEARING AID, UNITRON MODEL UF11 | Unitron Industries, Inc. | 1986-07-31 | Traditional | PDF ↗ |
| K862670 | RIONET HEARING AID HB-35PT | Rion Acoustic Instruments, Inc. | 1986-07-31 | Traditional | PDF ↗ |
| K862229 | PHONIC EAR PE 602 PPCS | Phonic Ear, Inc. | 1986-07-22 | Traditional | PDF ↗ |
| K862169 | ALPHA ALL-IN-THE-EAR HEARING AID | Authorized Hearing Systems, Inc. | 1986-07-22 | Traditional | PDF ↗ |
| K862545 | HEARING AID (ALL-IN-EAR) | Vibrasonic, Inc. | 1986-07-16 | Traditional | PDF ↗ |
| K862222 | INEARSET IES HEARING AID | Inearset, Inc. | 1986-07-16 | Traditional | PDF ↗ |
| K862095 | MODEL CA, HEARING AID | Fine-Tune | 1986-06-26 | Traditional | PDF ↗ |
| K862101 | MODEL UM IN-THE-CANAL HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1986-06-23 | Traditional | PDF ↗ |
| K861939 | MODEL PC HEARING AID | Fine-Tune | 1986-06-23 | Traditional | PDF ↗ |
| K862104 | MODEL UC SPECTRUM IN-THE-CANAL HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1986-06-23 | Traditional | PDF ↗ |
| K862050 | LIFESOUND CUSTOM ITE | Lifesounds, Inc. | 1986-06-23 | Traditional | PDF ↗ |
| K862100 | MODEL ED BEHIND-THE-EAR HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1986-06-23 | Traditional | PDF ↗ |
| K862036 | MODEL HP HEARING AID | Fine-Tune | 1986-06-23 | Traditional | PDF ↗ |
| K862099 | DAHLBERG MODEL EE BEHIND-THE-EAR HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1986-06-23 | Traditional | PDF ↗ |
| K862102 | MODEL KM IN-THE-CANAL HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1986-06-23 | Traditional | PDF ↗ |
| K862103 | MODEL UC IN-THE-CANAL HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1986-06-23 | Traditional | PDF ↗ |
| K861532 | RX-33S INTRA MINI CANAL MODULE | Rexton, Inc. | 1986-06-05 | Traditional | PDF ↗ |
| K861597 | BEHING-THE-EAR HEARING AID SERIES SP | Maico Hearing Instruments, Inc. | 1986-06-02 | Traditional | PDF ↗ |
| K861728 | RIONET HEARING AID | Rion Acoustic Instruments, Inc. | 1986-05-27 | Traditional | PDF ↗ |
| K861492 | HEARING AID (ALL IN THE EAR) | Crystal Tone Hearing Instruments | 1986-05-02 | Traditional | PDF ↗ |
| K854637 | LEE ELECTRONICS PAL | Lee Electronics | 1986-04-29 | Traditional | PDF ↗ |
| K861254 | MODEL ST HEARING AID | Fine-Tune | 1986-04-23 | Traditional | PDF ↗ |
| K860170 | VOROBA TECHNOLOGIES, ASSOC. QUANTUM HEARING AID | Voroba Technologies Assoc. | 1986-04-17 | Traditional | PDF ↗ |
| K854311 | EARLENS | Sound Acoustic Systems, Ltd. | 1986-04-14 | Traditional | PDF ↗ |
| K860670 | DAHLBERG MODEL UT IN-THE-EAR HEARING AID | Dahlberg Electronics, Inc. | 1986-04-11 | Traditional | PDF ↗ |
| K860759 | CHARISMA HEARING AID | Bernafon, Inc. | 1986-04-11 | Traditional | PDF ↗ |
| K860671 | DAHLBERG MODEL EF BEHIND-THE-EAR HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1986-04-03 | Traditional | PDF ↗ |
| K854124 | CRAIGWELL AID HA300 | Craigwell Electronics, Ltd. | 1986-03-26 | Traditional | PDF ↗ |
| K860512 | TELESTAR I, HEARING AID | The Florida Hearing Aid Service | 1986-03-17 | Traditional | PDF ↗ |
| K860035 | MODEL 353C HEARING AID | Telex Communications, Inc. | 1986-03-17 | Traditional | PDF ↗ |
| K860007 | AM 12, HEARING AID | Electone, Inc. | 1986-03-12 | Traditional | PDF ↗ |
| K860008 | AM 31, HEARING AID | Electone, Inc. | 1986-03-12 | Traditional | PDF ↗ |
| K860191 | PA PRESIDENTIAL II - HEARING AID | Electone, Inc. | 1986-03-12 | Traditional | PDF ↗ |
| K860244 | A & M 150 PP (HEARING AID) | Electone, Inc. | 1986-03-12 | Traditional | PDF ↗ |
| K855240 | BEHIND THE EAR HEARING AIDS MODEL | Bernafon, Inc. | 1986-03-12 | Traditional | PDF ↗ |
| K860190 | A & M DISCREET - HEARING AID | Electone, Inc. | 1986-03-12 | Traditional | PDF ↗ |
| K854834 | DAHLBERG MODEL KC IN-THE-EAR HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1986-03-04 | Traditional | PDF ↗ |
| K854438 | THE ANSWER HEARING AID | Electone, Inc. | 1986-02-24 | Traditional | PDF ↗ |
| K854742 | OTICON, CITEC CUSTOM MADE HEARING AID CANAL TYPE | Oticon Corp. | 1986-02-20 | Traditional | PDF ↗ |
| K854315 | HEARTECH MODEL IN TECH | Hearing Tech, Inc. | 1986-01-21 | Traditional | PDF ↗ |
| K854001 | CERTI-FORM | Beltone Electronics Corp. | 1985-12-31 | Traditional | PDF ↗ |
| K852656 | MODEL M HEARING AID | Magnatone Hearing Aid Corp. | 1985-12-27 | Traditional | PDF ↗ |
| K853967 | HI-TECH LAB MODEL CONCHA ALL IN EAR | Hi-Tech Laboratories, Inc. | 1985-12-27 | Traditional | PDF ↗ |
| K853895 | AUDTEX 85 | Cami, Inc. | 1985-12-20 | Traditional | PDF ↗ |
| K853942 | INT'L MODEL XE BEHIND-THE-EAR HEARING AID | Int'L Hearing Aids, Inc. | 1985-12-18 | Traditional | PDF ↗ |
| K853941 | INT'L MODEL XG BEHIND-THE-EAR HEARING AID | Int'L Hearing Aids, Inc. | 1985-12-18 | Traditional | PDF ↗ |
| K853793 | WIDEX MODEL M1 | Widex Hearing Aid Co., Inc. | 1985-12-02 | Traditional | PDF ↗ |
| K853381 | OE SERIES OF BEHIND-THE-EAR HEARING AIDS | Emtech Laboratories | 1985-11-08 | Traditional | PDF ↗ |
| K852244 | HEARING AID(ALL IN EAR) | Olympia Instruments, Inc. | 1985-11-07 | Traditional | PDF ↗ |
| K853780 | UNITRON MODEL UM60-D | Unitron Industries, Inc. | 1985-11-07 | Traditional | PDF ↗ |
| K853781 | UNITRON MODEL UM60-PP | Unitron Industries, Inc. | 1985-11-07 | Traditional | PDF ↗ |
| K853605 | PERSONAL AMPLIFIER SLIMLINE III | Electone, Inc. | 1985-11-01 | Traditional | PDF ↗ |
| K853172 | INTERNATIONAL MODEL SC CANAL IN THE EAR HEARING AI | Int'L Hearing Aids, Inc. | 1985-10-17 | Traditional | PDF ↗ |
| K853170 | INTERNATIONAL MODEL SC CUSTOM IN THE EAR HEARG AID | Int'L Hearing Aids, Inc. | 1985-10-04 | Traditional | PDF ↗ |
| K853171 | INTERNATIONAL MODEL SC SEMICANAL IN THE EAR HEAR A | Int'L Hearing Aids, Inc. | 1985-10-01 | Traditional | PDF ↗ |
| K853324 | DAHLBERG EB BEHING-THE-EAR HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1985-09-23 | Traditional | PDF ↗ |
| K853264 | HEARING AID MODEL 337D | Telex Communications, Inc. | 1985-09-23 | Traditional | PDF ↗ |
| K853220 | HEARTECH MODEL ILLUSION | Hearing Tech, Inc. | 1985-09-23 | Traditional | PDF ↗ |
| K853638 | RIONET HEARING AID | Rion Acoustic Instruments, Inc. | 1985-09-23 | Traditional | PDF ↗ |
| K853636 | RIONET HEARING AID HI-06 | Rion Acoustic Instruments, Inc. | 1985-09-23 | Traditional | PDF ↗ |
| K853606 | PERSONAL AMPLIFIER COMMUNICATOR PREMIUM | Electone, Inc. | 1985-09-23 | Traditional | PDF ↗ |
| K853325 | DAHLBERG EC BEHIND-THE-EAR HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1985-09-23 | Traditional | PDF ↗ |
| K853323 | DAHLBERG EA BEHING-THE-EAR HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1985-09-23 | Traditional | PDF ↗ |
| K853637 | RIONET HEARING AID HI-07 | Rion Acoustic Instruments, Inc. | 1985-09-23 | Traditional | PDF ↗ |
| K853218 | HEARTECH MODEL(HTC) (HERITAGE) | Hearing Tech, Inc. | 1985-09-23 | Traditional | PDF ↗ |
| K853219 | HEARTECH MODEL CH | Hearing Tech, Inc. | 1985-09-23 | Traditional | PDF ↗ |
| K853173 | INTERNATION MODEL SS STOCK CANAL IN THE EAR H.A. | Int'L Hearing Aids, Inc. | 1985-09-06 | Traditional | PDF ↗ |
| K852453 | RIONET HEARING AID HB-69HT | Rion Acoustic Instruments, Inc. | 1985-08-22 | Traditional | PDF ↗ |
| K852486 | DAH/BERG MODEL HP BEHIND-THE-EAR HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1985-08-22 | Traditional | PDF ↗ |
| K853108 | MODEL 372L HEARING AID | Telex Communications, Inc. | 1985-08-22 | Traditional | PDF ↗ |
| K852451 | RIONET HEARING AID HB-34HT | Rion Acoustic Instruments, Inc. | 1985-08-21 | Traditional | PDF ↗ |
| K852452 | RIONET HEARING AID HB-71P | Rion Acoustic Instruments, Inc. | 1985-08-21 | Traditional | PDF ↗ |
| K852052 | HEARING AID(ALL IN THE EAR(ALL IN THE CANAL | Penn-Tech Laboratories | 1985-08-16 | Traditional | PDF ↗ |
| K852098 | DAHLBERG MODEL US SPECTRUM IN-THE-EAR HEARING AID | Miracle-Ear/Dahlberg, Inc. | 1985-08-16 | Traditional | PDF ↗ |
Product code ESD · Class I · Ear, Nose, Throat. Data: openFDA.