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
889–912 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Dec 03, 2002
DAUM-LECTRIC MRI DRILLING MACHINE
K021098 · ERL
Mri Devices Daum GmbH
Ear, Nose, Throat · 243d
Cleared Nov 19, 2002
INSOUND XT SERIES HEARING AID
K021867 · ESD
Insound Medical, Inc.
Ear, Nose, Throat · 166d
Cleared Nov 18, 2002
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310,...
K023337 · KTI
Boston Scientific Corp
Ear, Nose, Throat · 42d
Cleared Oct 24, 2002
GYRUS ENT NERVE STIMULATOR
K021595 · ETN
Gyrus Ent LLC
Ear, Nose, Throat · 162d
Cleared Oct 16, 2002
EB-1830T3, VIDEO BRONCHOSCOPE
K023376 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 8d
Cleared Oct 11, 2002
REUSABLE BRONCHIAL BIOPSY FORCEPS
K022398 · BWH
Ballard Medical Products
Ear, Nose, Throat · 80d
Cleared Oct 11, 2002
AUDIOTRAVELLER, MODEL AA222
K022728 · ETY
Interacoustics A/S, Assens
Ear, Nose, Throat · 56d
Cleared Oct 09, 2002
REPROCESSED DISPOSABLE TROCARS
K022743 · KAB
Medical Device Services
Ear, Nose, Throat · 51d
Cleared Oct 01, 2002
SNIFF POSITION PILLOWS/POPITZ PILLOWS
K023010 · MYB
Aeolus International Corporation
Ear, Nose, Throat · 22d
Cleared Aug 30, 2002
BRANENMARK BONE-ANCHORED-HEARING AID (BAHA)
K021837 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 87d
Cleared Aug 27, 2002
FONIX, MODEL 7000
K022510 · ETW
Frye Electronics, Inc.
Ear, Nose, Throat · 28d
Not Cleared Aug 20, 2002
RETROX
DEN020003 · NIX
Auric Hearing Systems, Inc.
Ear, Nose, Throat · 60d
Cleared Aug 12, 2002
HORIZONS ANSO TRANSBRONCHIAL ASPIRATION NEEDLES
K022546 · EOQ
Horizons Intl. Corp.
Ear, Nose, Throat · 11d
Cleared Jul 30, 2002
PROVOX FREEHANDS HME, MODEL 7710
K022125 · EWL
Atos Medical AB
Ear, Nose, Throat · 29d
Cleared Jul 15, 2002
VISION SCIENCES ENDOSHEATH SYSTEM
K012543 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 342d
Cleared Jul 13, 2002
ULTRAQUIET
K021202 · KLW
Sound Technique System, LLC
Ear, Nose, Throat · 88d
Cleared Jun 27, 2002
BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS
K021801 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 24d
Cleared Jun 25, 2002
ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
K020296 · EWD
Apothecary Products, Inc.
Ear, Nose, Throat · 148d
Cleared Jun 19, 2002
UNIDRIVE II PLUS DISPOSABLE TUBING SET
K021811 · ERL
Mtp Medical Technical Promotion GmbH
Ear, Nose, Throat · 16d
Cleared May 24, 2002
B-F200 BRONCHOSCOPE WITH BSS-F21 ENDOSHEATH SYSTEM
K021344 · EOQ
Vision-Sciences, Inc.
Ear, Nose, Throat · 25d
Cleared May 21, 2002
TST - SUPPRESSOR MODEL #1000
K013827 · KLW
Neurosim Limited
Ear, Nose, Throat · 183d
Cleared May 21, 2002
CLIP PISTON AWENGEN, MODEL# 1006 805 - 1006 861
K021479 · ETB
Heinz Kurz GmbH Medizintechnik
Ear, Nose, Throat · 13d
Cleared May 01, 2002
VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V
K021073 · EOB
Olympus America, Inc.
Ear, Nose, Throat · 29d
Cleared Apr 17, 2002
NICOLET ELECTROCAUTERY DETECTOR
K020955 · ETN
Nicolet Biomedical, Inc.
Ear, Nose, Throat · 23d