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
1465–1488 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Oct 27, 1995
TREBAY TOTAL RECTANGULAR HEAD
K954518 · ETA
Trebay Medical Corp.
Ear, Nose, Throat · 29d
Cleared Oct 27, 1995
MICRO-PLANER HANDPIECE
K954715 · ERL
Trebay Medical Corp.
Ear, Nose, Throat · 15d
Cleared Oct 24, 1995
TYMPANOSTOMY TUBE
K953802 · ETD
Bluff City Medical Technologies, Inc.
Ear, Nose, Throat · 78d
Cleared Oct 20, 1995
BREATHE RIGHT NASAL STRIP
K953772 · LWF
Cns, Inc.
Ear, Nose, Throat · 67d
Cleared Oct 19, 1995
BIOFEEDBACK SYSTEM FOR SPEECH DISORDERS
K942651 · KTH
Casa Futura Technologies
Ear, Nose, Throat · 503d
Cleared Oct 18, 1995
EASY BREATHING NASAL STRIPS
K954252 · LWF
Corbett Lair, Inc.
Ear, Nose, Throat · 37d
Cleared Oct 18, 1995
WIDEX SENSO DIGITAL (PX)
K954526 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 19d
Cleared Oct 07, 1995
UNITRON MODEL IKON AOHPD
K953727 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 58d
Cleared Oct 07, 1995
TELESCOPE 4MM, 2.7MM DIAM. WIDE ANGLE 0', 30', 70', 4MM, DIAM, 30' WORK, L...
K953888 · EOB
Vista Medical Technologies, Inc.
Ear, Nose, Throat · 51d
Cleared Oct 07, 1995
UNITRON MODEL SOUND F/XD
K953932 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 61d
Cleared Oct 07, 1995
UNITRON MODEL SOUND F/X II
K954516 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 9d
Cleared Oct 07, 1995
MIRACLE - EAR MODEL PBP
K954528 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 8d
Cleared Oct 06, 1995
SAUER ENDOSCOPE GUIDE AND INTUBATION AID
K954125 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 35d
Cleared Oct 06, 1995
UNITRON MODEL SOUND F/X
K954430 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 14d
Cleared Sep 28, 1995
MAICO PRODIGY CIC SERIES
K954054 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 30d
Cleared Sep 28, 1995
3M MODEL 8295
K954067 · ESD
3M Company
Ear, Nose, Throat · 29d
Cleared Sep 26, 1995
DISTENDING DIVERTICULOSCOPE
K953596 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 56d
Cleared Sep 18, 1995
AMENDMENTS TO MULTIFOCUS
K951002 · ESD
Oticon A/S
Ear, Nose, Throat · 203d
Cleared Sep 18, 1995
REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILY
K953770 · ESD
Rexton, Inc.
Ear, Nose, Throat · 35d
Cleared Sep 18, 1995
PHONAK 9900 CIC
K953921 · ESD
Phonak, Inc.
Ear, Nose, Throat · 28d
Cleared Sep 18, 1995
K-AMP 16, HI-BAND K-AMP, ULTRA COMPRESSION & HEARING PROTECTION/HEARING...
K954038 · ESD
Argosy Electronics
Ear, Nose, Throat · 21d
Cleared Sep 15, 1995
VIDEO SCOPE SYSTEM (LARYNGOSCOPE)
K944032 · ENZ
Jedmed Instrument Co.
Ear, Nose, Throat · 394d
Cleared Sep 12, 1995
HEARING AID (ALL-IN-THE-EAR)
K951712 · ESD
Omega Hearing Aid Center
Ear, Nose, Throat · 152d
Cleared Sep 12, 1995
RX12 LINEAR FULL SHELL AND IN THE CANAL
K953728 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 33d