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
1753–1776 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 22, 1994
SIEMENS BTE HEARING AIDS
K942857 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 67d
Cleared Aug 22, 1994
AUDILENS LLK
K943706 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 21d
Cleared Aug 19, 1994
KS 5 - CLINICAL AUDIOMETER
K931322 · EWO
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 521d
Cleared Aug 18, 1994
ESOPHAGOSCOPE AND ACCESSORIES
K943667 · EOX
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 21d
Cleared Aug 18, 1994
MO6 SERIES
K943670 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 23d
Cleared Aug 17, 1994
TAS-(VARIOUS) ULTRATHIN FLEXIBLE ENDOSCOPE
K942388 · EOQ
Technology Marketing Group
Ear, Nose, Throat · 90d
Cleared Aug 17, 1994
MIRACLE-EAR MODEL PGF + REMOTE
K942893 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 58d
Cleared Aug 17, 1994
MIRACLE-EAR MODEL PGC
K942894 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 58d
Cleared Aug 17, 1994
MIRACLE EAR MODEL PGM
K942895 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 58d
Cleared Aug 17, 1994
INTERACOUSTICS CLINICAL AUDIOMETER
K943065 · EWO
Precision Acoustics Ind., Inc.
Ear, Nose, Throat · 50d
Cleared Aug 17, 1994
MEDNEXT MICRO-DRILL
K943108 · ERL
Mednext, Inc.
Ear, Nose, Throat · 49d
Cleared Aug 17, 1994
SM-VEGA, SM-PC, SM-AGC, SM-AGC-H
K943682 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 22d
Cleared Aug 12, 1994
MISTASSIST
K942789 · LRD
The Merlin Corp.
Ear, Nose, Throat · 59d
Cleared Aug 09, 1994
STARKEY CE-8 TML, STARKEY CE-8 TMC AIR CONDUCTION HEARING AID
K940667 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 174d
Cleared Aug 09, 1994
THE CANAL (C.I.C.) AKA/HIDDEN EAR
K941107 · ESD
Qualitone, Inc.
Ear, Nose, Throat · 155d
Cleared Aug 09, 1994
WATER IRRIGATOR, W1 200
K941325 · KHH
Strong Medical, Inc.
Ear, Nose, Throat · 144d
Cleared Aug 09, 1994
CRYSTAL EAR
K942189 · ESD
Crystal Care Intl., Inc.
Ear, Nose, Throat · 97d
Cleared Aug 09, 1994
PHILIPS M38 SERIES
K943395 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 26d
Cleared Aug 04, 1994
EARCRAFT HEARING AID
K940670 · ESD
Earcraft, Inc.
Ear, Nose, Throat · 169d
Cleared Aug 02, 1994
FORCEPS, PUNCHES, SCISSORS
K943074 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 35d
Cleared Jul 29, 1994
BELTONE SERIES 100 AUDIOMETERS
K940216 · EWO
Beltone Electronics Corp.
Ear, Nose, Throat · 196d
Cleared Jul 29, 1994
AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS
K942158 · EPP
Wfr/Aquaplast Corp.
Ear, Nose, Throat · 87d
Cleared Jul 25, 1994
MIRACLE-EAR EAR IMPRESSION MATERIAL
K941859 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 101d
Cleared Jul 20, 1994
STIMULATING SURGICAL INSTRUMENTS
K934733 · ETN
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 292d