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
2113–2136 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Sep 09, 1992
ENDOPATH TISSUE RETAINING COMPONENT
K923679 · KCJ
Ethicon Endo-Surgery, Inc.
Ear, Nose, Throat · 49d
Cleared Sep 04, 1992
SINGH SPEECH SYSTEM (SERIES 'SSS')
K912486 · EWL
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 458d
Cleared Sep 04, 1992
OMEGA OTO NASOPHARYNGO-LARYNGOSCOPE
K920439 · EOB
Omega Universal Technologies, Ltd.
Ear, Nose, Throat · 214d
Cleared Sep 04, 1992
STARKEY LABORATORIES OTOSCOPE
K922752 · ERA
Starkey Laboratories, Inc.
Ear, Nose, Throat · 88d
Cleared Aug 26, 1992
STARKEY SM SERIES BTE HEARING AIDS
K923784 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 29d
Cleared Aug 24, 1992
GROUP AUDITORY TRAINING SYSTEM
K922720 · EPF
Phonic Ear, Inc.
Ear, Nose, Throat · 80d
Cleared Aug 24, 1992
VOICEWAVE
K923924 · ESD
Personal Sound Technologies, Inc.
Ear, Nose, Throat · 19d
Cleared Aug 20, 1992
IMAGICA MICRO-ENDOSCOPE
K921393 · EOQ
Fiberoptic Medical Products, Inc.
Ear, Nose, Throat · 150d
Cleared Aug 18, 1992
SIEMENS MODEL INFINITI 1001 B
K923379 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 40d
Cleared Aug 18, 1992
SIEMENS MODEL TRITON 3004 B
K923380 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 40d
Cleared Aug 14, 1992
ACOUSTIC APPRAISE CD-3
K923013 · EWO
Qualitone
Ear, Nose, Throat · 53d
Cleared Aug 11, 1992
PHILIP XP SERIES, IN-THE CANAL HEARING AID
K921725 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 124d
Cleared Aug 06, 1992
LAPAROMED LIGATING LOOP
K921053 · KCJ
Laparomed Corp.
Ear, Nose, Throat · 154d
Cleared Aug 06, 1992
RESOUND PERSONAL HEARING SYSTEM SOUNDLINK-1
K922570 · EPF
Resound Corp.
Ear, Nose, Throat · 66d
Cleared Aug 06, 1992
BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER
K923388 · ESD
Oticon Corp.
Ear, Nose, Throat · 30d
Cleared Aug 06, 1992
BTE HEARING AID PERSONIC 410
K923490 · ESD
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Aug 06, 1992
BTE HEARING AID PERSONIC 425
K923491 · ESD
Oticon Corp.
Ear, Nose, Throat · 23d
Cleared Jul 30, 1992
EURION LOTOS PP HEARING AID
K923226 · ESD
Eurion Hearing Instruments
Ear, Nose, Throat · 29d
Cleared Jul 23, 1992
NASAL SEPTAL SPLINT
K921195 · LYA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 133d
Cleared Jul 23, 1992
TURBINATE NASAL SPLINT
K921202 · LYA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 133d
Cleared Jul 17, 1992
LX 150 LIGHT SOURCE
K922095 · EQH
Welch Allyn, Inc.
Ear, Nose, Throat · 73d
Cleared Jul 10, 1992
ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID
K922392 · ESD
A-1 Hearing Aid Lab
Ear, Nose, Throat · 51d
Cleared Jul 08, 1992
EPISTAXIS NASAL BALLOON CATHETER
K921199 · EMX
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 118d
Cleared Jul 06, 1992
A-ZILICONE
K905555 · ESD
Oticon Corp.
Ear, Nose, Throat · 573d