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
1825–1848 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared May 05, 1994
TYMPOVENT
K936275 · ETD
Atos Medical AB
Ear, Nose, Throat · 126d
Cleared May 04, 1994
MIRACLE-EAR WITH POWER CIRCUIT OPTION
K935962 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 142d
Cleared May 04, 1994
MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER
K940521 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 89d
Cleared May 04, 1994
155 PP AGC-I
K940608 · ESD
Danavox, Inc.
Ear, Nose, Throat · 79d
Cleared May 04, 1994
STARKEY EUROLINE A SERIES
K940978 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 64d
Cleared May 04, 1994
RIONET HEARING AID HB-54
K941021 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 62d
Cleared May 04, 1994
RIONET HEARING AID HB-37T
K941140 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 55d
Cleared May 04, 1994
FLEXIBLE GRASPING FORCEPS
K941161 · EOQ
Surgical Technologies, Inc.
Ear, Nose, Throat · 54d
Cleared May 04, 1994
BELTON MERIT (HEARING AID)
K941395 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 43d
Cleared May 04, 1994
WIDEX S-21
K941508 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 36d
Cleared May 04, 1994
INTRA S, INTRA SH
K941635 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared May 04, 1994
MINI PAK
K941636 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 30d
Cleared May 03, 1994
COMPLETELY IN THE CANAL
K940116 · ESD
Argosy Electronics
Ear, Nose, Throat · 113d
Cleared Apr 28, 1994
FLEXIBLE BIOPSY CUP FORCEPS
K941158 · EOQ
Surgical Technologies, Inc.
Ear, Nose, Throat · 48d
Cleared Apr 26, 1994
AURAL-CAM, VIDEO EAR, VID RX
K941659 · ERA
Gracefully Yours, Inc.
Ear, Nose, Throat · 21d
Cleared Apr 25, 1994
OTOVIEW ENDOSCOPY SYSTEM
K934432 · EWA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 224d
Cleared Apr 22, 1994
PRODIGIT 2000
K940999 · EWO
Calmed Technology, Inc.
Ear, Nose, Throat · 49d
Cleared Apr 15, 1994
BLOM-SINGER INDWELLING LOW PRESSURE VOICE PROSTHES
K932120 · EWL
Helix Medical, Inc.
Ear, Nose, Throat · 347d
Cleared Apr 14, 1994
TONSIL SPONGE, GAUZE DISSECTOR, CYLINDRICAL SPONGES
K940903 · KBM
Medical Insights, Inc.
Ear, Nose, Throat · 49d
Cleared Apr 04, 1994
BEHIND THE EAR HEARING AID
K936190 · ESD
Audina Hearing Instrument
Ear, Nose, Throat · 98d
Cleared Apr 01, 1994
MID LABS TWIN ILLUMINATOR
K932131 · EQH
Medical Instrument Development...
Ear, Nose, Throat · 333d
Cleared Apr 01, 1994
OTOSONIC (OSI) LPS D
K940099 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
PROFILE IC
K940100 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 81d
Cleared Apr 01, 1994
OTOSONIC ACS II D WITH SRR
K940101 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 81d