FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,812 results
2329–2352 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Mar 15, 1991
ITE HEARING AID
K905371 · ESD
Audicare Hearing Center
Ear, Nose, Throat · 106d
Cleared Mar 13, 1991
3M MODEL 8240 ITE HEARING AID
K910690 · ESD
3M Company
Ear, Nose, Throat · 22d
Cleared Mar 08, 1991
543 SERIES BTE
K905680 · ESD
Hearing Tech, Inc.
Ear, Nose, Throat · 79d
Cleared Mar 08, 1991
POST AURICULAR HEARING AID MODEL PICO SC-H
K910028 · ESD
Phonak, Inc.
Ear, Nose, Throat · 63d
Cleared Feb 28, 1991
BLOM-SINGER SHOWER GUARD
K904729 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 134d
Cleared Feb 28, 1991
PHONAK MODEL PICO C-S-H-T, BTE HEARING AID
K910012 · ESD
Phonak, Inc.
Ear, Nose, Throat · 57d
Cleared Feb 28, 1991
POST AURICULAR HEARING AID MODEL PICO-FORTE PP-SC
K910018 · ESD
Phonak, Inc.
Ear, Nose, Throat · 55d
Cleared Feb 28, 1991
ACTIVE MODEL AST CUSTOM ITE HEARING AID
K910700 · ESD
Active Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Feb 28, 1991
ACTIVE MODEL ALP LOW PROFILE ITE HEARING AID
K910701 · ESD
Active Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Feb 28, 1991
ACTIVE MODEL AHS HALF SHELL ITE HEARING AID
K910702 · ESD
Active Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Feb 28, 1991
ACTIVE MODEL ACA CUSTOM CANAL ITE HEARING AID
K910703 · ESD
Active Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Feb 28, 1991
ACTIVE MODEL AMC MINI CANAL ITE HEARING AID
K910704 · ESD
Active Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Feb 28, 1991
ACTIVE MODEL AHX HELIX ITE HEARING AID
K910705 · ESD
Active Electronics, Inc.
Ear, Nose, Throat · 8d
Cleared Feb 28, 1991
PHILIPS MODEL S46-OL BTE HEARING AID
K910743 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 7d
Cleared Feb 28, 1991
PHILIPS MODEL S46-O BTE HEARING AID
K910744 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 7d
Cleared Feb 28, 1991
3M MODEL 8241 ITE HEARING AID
K910759 · ESD
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8242 ITE HEARING AID
K910760 · ESD
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8243 ITE HEARING AID
K910761 · ESD
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8244 ITE HEARING AID
K910762 · ESD
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 28, 1991
3M MODEL 8245 ITE HEARING AID
K910763 · ESD
3M Company
Ear, Nose, Throat · 9d
Cleared Feb 20, 1991
MIDDLE EAR ANALYZER, MODEL AE-803
K905213 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 92d
Cleared Feb 19, 1991
IMMITTANCE METER, MODEL AE-105D/S
K905212 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 91d
Cleared Feb 05, 1991
PHILIPS MODEL S47 BTE HEARING AID
K910206 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 20d
Cleared Jan 29, 1991
ACOUSTIQ LISTENING DEVICE
K904755 · LZI
Krueger Laboratories
Ear, Nose, Throat · 102d