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
3073–3096 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 17, 1984
BLOM-SINGER LOW PRESSURE VOICE PROSTHES
K842896 · EWL
American V. Mueller
Ear, Nose, Throat · 25d
Cleared Aug 14, 1984
RIONET HEARING AID HI-03
K841935 · ESD
Rion Acoustic Instruments, Inc.
Ear, Nose, Throat · 95d
Cleared Aug 10, 1984
TISSUE INTEGRATED PROSTHESIS DRILL
K841813 · ERL
Bofors Nobelpharma, Inc.
Ear, Nose, Throat · 101d
Cleared Aug 10, 1984
RADIOEAR M420H
K841933 · ESD
Radioear Corp.
Ear, Nose, Throat · 91d
Cleared Aug 02, 1984
CONFERETTE C2
K840893 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 157d
Cleared Aug 02, 1984
POST-AID
K840907 · KCM
E.W. Link, Inc.
Ear, Nose, Throat · 156d
Cleared Aug 02, 1984
MONTG. LARYNGEAL KEEL
K842800 · FWN
Boston Medical Products, Inc.
Ear, Nose, Throat · 16d
Cleared Jul 18, 1984
ELEVATOR
K841356 · KAD
Treace Medical, Inc.
Ear, Nose, Throat · 107d
Cleared Jul 18, 1984
IMPEDANCE/PURE TONE AUDIOMETER MA620
K841568 · ETY
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 92d
Cleared Jul 18, 1984
GLOTTAL FREQUENCY ANALYSER
K841832 · KLX
Teltec Electronic Equipment AB
Ear, Nose, Throat · 76d
Cleared Jul 18, 1984
RHINO-LARYNX STROBOSCOPE TYPE 4914
K842090 · EQL
Bruel & Kjaer Industri A/S
Ear, Nose, Throat · 55d
Cleared Jul 16, 1984
BRIMFIELD FIBEROPTIC LIGHT SCOURCE
K841731 · EQH
Brimfield Scientific Instruments
Ear, Nose, Throat · 81d
Cleared Jul 13, 1984
DISPOSA-SPEC
K840593 · ERA
Plasti-Products, Inc.
Ear, Nose, Throat · 155d
Cleared Jul 11, 1984
RELIABLE
K834479 · LRB
Reliable Hearing Aide
Ear, Nose, Throat · 204d
Cleared Jul 06, 1984
CAUSSE SPONGE BOAT
K841353 · ETB
Treace Medical, Inc.
Ear, Nose, Throat · 95d
Cleared Jul 06, 1984
CURETTE
K841354 · JYG
Treace Medical, Inc.
Ear, Nose, Throat · 95d
Cleared Jul 03, 1984
RIGHT ANGLED PICK
K841355 · JYT
Treace Medical, Inc.
Ear, Nose, Throat · 92d
Cleared Jun 27, 1984
DEMLAR SYS I COMPUTER BASED AUDIOMETER
K841167 · EWO
Demlar Medical, Inc.
Ear, Nose, Throat · 100d
Cleared Jun 27, 1984
OTICON E28A
K841436 · ESD
Oticon Corp.
Ear, Nose, Throat · 82d
Cleared Jun 27, 1984
AUDIOMETER MA728
K841567 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 71d
Cleared Jun 27, 1984
MONTGOMERY LARYNGEAL STENT
K842287 · FWN
Boston Medical Products, Inc.
Ear, Nose, Throat · 12d
Cleared Jun 22, 1984
IN-THE-EAR HEARING AID MODEL
K833486 · ESD
Danavox, Inc.
Ear, Nose, Throat · 259d
Cleared Jun 22, 1984
SHEA MIDDLE EAR MICRODRILL
K833874 · ERL
Applied Research Corp.
Ear, Nose, Throat · 227d
Cleared Jun 22, 1984
SHEA FOOTPLATE MICRODRILL
K833875 · ERL
Applied Research Corp.
Ear, Nose, Throat · 227d