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
3193–3216 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jun 24, 1983
AUSTIN MODIFIED TOTAL OSSICULAR REPLACE
K823912 · ETA
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 24, 1983
PARTIAL OSSICULAR REPLACEMENT
K823917 · ETA
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 24, 1983
AUSTIN MODIFIED PARTIAL OSSICULAR RE-
K823918 · ETA
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 24, 1983
TOTAL OSSICULAR REPLACEMENT
K823919 · ETA
Treace Medical, Inc.
Ear, Nose, Throat · 178d
Cleared Jun 16, 1983
VENT TUBE FORCEPS
K831589 · EQH
Treace Medical, Inc.
Ear, Nose, Throat · 30d
Cleared Jun 15, 1983
T-TUBE INSERTER
K831590 · EQH
Treace Medical, Inc.
Ear, Nose, Throat · 29d
Cleared Jun 02, 1983
SOILEAU TYTAN BOBBIN VENT TUBE
K830584 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 99d
Cleared May 09, 1983
WIDEX HEARING AID #G2H & G2T
K830465 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 83d
Cleared May 09, 1983
MODEL 343D HEARING AID
K831197 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 27d
Cleared May 09, 1983
MODEL BERNAFON T-86
K831217 · ESD
Bernafon, Inc.
Ear, Nose, Throat · 24d
Cleared Apr 27, 1983
PERSONAL ROMEAR
K823588 · ESD
Romear Mfg., Inc.
Ear, Nose, Throat · 142d
Cleared Apr 27, 1983
COOL-LITE FIBERCOPTIC LARYNGEAL EXAM
K830888 · EQN
National Medical Technology
Ear, Nose, Throat · 37d
Cleared Mar 29, 1983
MECON I
K823788 · ESD
Mecon Labs
Ear, Nose, Throat · 103d
Cleared Mar 28, 1983
PHYSICIANS CHOICE SILICONE EAR PUTTY
K823921 · LDG
Santa Barbara Medco, Inc.
Ear, Nose, Throat · 90d
Cleared Mar 24, 1983
RIONET HEARING AID
K830236 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 58d
Cleared Mar 17, 1983
T-TUBE VENT TUBE
K823909 · ETD
Treace Medical, Inc.
Ear, Nose, Throat · 79d
Cleared Mar 10, 1983
TACTAID
K830418 · LRA
Audiological Engineering Corp.
Ear, Nose, Throat · 30d
Cleared Mar 10, 1983
OTICON, E25P
K830435 · ESD
Octicon Corp.
Ear, Nose, Throat · 29d
Cleared Mar 10, 1983
OTICON, E-27P
K830436 · ESD
Octicon Corp.
Ear, Nose, Throat · 29d
Cleared Mar 09, 1983
ENDECO ACOUSTIC OTOSCOPE
K830139 · ETY
Endeco Medical, Inc.
Ear, Nose, Throat · 55d
Cleared Mar 07, 1983
OTOLOGICAL VENTILATION TUBES-VARIOUS
K830228 · ETD
Micromedics, Inc.
Ear, Nose, Throat · 42d
Cleared Mar 07, 1983
800 BLUE
K830303 · ESD
Electone, Inc.
Ear, Nose, Throat · 38d
Cleared Mar 07, 1983
HEARING AID, #UE7-D
K830402 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 28d
Cleared Mar 07, 1983
BEHIND THE EAR HEARING AID OMNI #OS
K830459 · ESD
Omni Hearing Systems
Ear, Nose, Throat · 20d