FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,798 results
2257–2280 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 26, 1991
MAICO MA800 AUDIOMETER
K911368 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 90d
Cleared Jun 26, 1991
SIEMENS MODEL 604 PP, BEHIND-THE-EAR HEARING AID
K911810 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 64d
Cleared Jun 26, 1991
SIEMENS MODEL 604 PP-L, BEHIND-THE-EAR HEARING AID
K911811 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 64d
Cleared Jun 26, 1991
PHONAK PHONICA MODEL 312-C ITE HEARING INSTRUMENT
K912570 · ESD
Phonak, Inc.
Ear, Nose, Throat · 15d
Cleared Jun 26, 1991
PHONAK PHONICA MODEL 312-SC ITE HEARING INSTRUMENT
K912571 · ESD
Phonak, Inc.
Ear, Nose, Throat · 15d
Cleared Jun 24, 1991
SEAL-RITE SILICONE EAR PLUG
K910177 · EWD
Flents Products Co., Inc.
Ear, Nose, Throat · 160d
Cleared Jun 21, 1991
SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES
K904239 · ETA
Microbio-Medics, Inc.
Ear, Nose, Throat · 281d
Cleared Jun 20, 1991
TELEX MODEL TLP, IN-THE-EAR
K912204 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 31d
Cleared Jun 19, 1991
ZODIAC 901 MIDDLE-EAR ANALYZER
K910247 · ETY
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 148d
Cleared Jun 17, 1991
QUILTONE MODEL 48 PP-AGC-I-D-BEHIND THE EAR
K912153 · ESD
Qualitone
Ear, Nose, Throat · 33d
Cleared Jun 17, 1991
QUALITONE MODEL 48 C-WR-BEHIND THE EAR
K912154 · ESD
Qualitone
Ear, Nose, Throat · 33d
Cleared Jun 07, 1991
PHILIPS M30 IN-THE-EAR HEARING AID
K912339 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 14d
Cleared May 30, 1991
RIVER MEDICAL MICRODRILL SYSTEM
K905437 · EQH
River Medical, Inc.
Ear, Nose, Throat · 177d
Cleared May 30, 1991
FACEPLATE ITE HEARING AID MODEL TCA
K910900 · LRB
Telex Communications, Inc.
Ear, Nose, Throat · 86d
Cleared May 30, 1991
FACEPLATE ITE HEARING AID MODEL 28A
K910901 · LRB
Telex Communications, Inc.
Ear, Nose, Throat · 86d
Cleared May 28, 1991
WIDEX MODEL QX IN-THE-EAR HEARING AID
K912169 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 12d
Cleared May 23, 1991
LM-150HT LIGHT SOURCE
K911212 · ESI
Leisegang Medical, Inc.
Ear, Nose, Throat · 65d
Cleared May 17, 1991
CHAMPION, BEHIND-THE-EAR HEARING AID
K911705 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
MODEL 800, BEHIND-THE-EAR HEARING AID
K911706 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
REGAL, BEHIND-THE-EAR HEARING AID
K911707 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
MODEL E-50, IN-THE-EAR HEARING AID
K911708 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 17, 1991
STOCK CANAL, IN-THE-EAR HEARING AID
K911709 · ESD
Electone, Inc.
Ear, Nose, Throat · 31d
Cleared May 15, 1991
#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES
K910781 · ETF
Midmark Corp.
Ear, Nose, Throat · 79d
Cleared May 09, 1991
NHS 2009SP HEARING AID
K911174 · ESD
Magnatone Hearing Aid Corp.
Ear, Nose, Throat · 52d