FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,798 results
1441–1464 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 13, 1995
JED-LIGHT FIBEROPTIC LIGHT SOURCE
K954184 · EQH
Jedmed Instrument Co.
Ear, Nose, Throat · 68d
Cleared Nov 13, 1995
ENDO-BEND GRASPER (114.3 MM SHAFT-STERILE)
K954336 · EOB
Aust & Taylor Medical Corp.
Ear, Nose, Throat · 56d
Cleared Nov 13, 1995
OTICON
K954794 · ESD
Oticon, Inc.
Ear, Nose, Throat · 26d
Cleared Nov 13, 1995
COAST HEARING CHS (CUSTOM HEARING SYSTEM)
K954937 · ESD
Coast Hearing Services
Ear, Nose, Throat · 189d
Cleared Nov 06, 1995
MICRO-INGRESSOR HANDIPIECE
K954796 · ERL
Trebay Medical Corp.
Ear, Nose, Throat · 19d
Cleared Nov 03, 1995
KARL STORZ OPTICAL MEDIASTINOSCOPE
K954910 · EWY
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 9d
Cleared Oct 27, 1995
BURGET NASAL STENT
K942025 · LWF
Bivona Medical Technologies
Ear, Nose, Throat · 549d
Cleared Oct 27, 1995
GSI 61 CLINICAL AUDIOMETER
K953684 · EWO
Grason-Stadler, Inc.
Ear, Nose, Throat · 85d
Cleared Oct 27, 1995
PROPHET
K953884 · EWO
Qualitone
Ear, Nose, Throat · 71d
Cleared Oct 27, 1995
TREBAY PARTIAL RECTRANGULAR HEADS, MORETZ CAM, INCUS/STAPEDIAL JOINT &...
K954517 · ETB
Trebay Medical Corp.
Ear, Nose, Throat · 29d
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