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
1633–1656 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jan 27, 1995
3M(TM) EAR IMPRESSION MATERIAL
K945726 · ESD
3M Medical Products Group
Ear, Nose, Throat · 66d
Cleared Jan 26, 1995
OPTUS SINUSCOPES AND ACCESSORIES
K944656 · EOB
Optus, Inc.
Ear, Nose, Throat · 127d
Cleared Jan 26, 1995
UNITRON MODEL SOUNG F/S
K946264 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 34d
Cleared Jan 26, 1995
PHONAK SONO-FORTE 332X-AZ
K946294 · ESD
Phonak, Inc.
Ear, Nose, Throat · 30d
Cleared Jan 25, 1995
KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES
K945788 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 61d
Cleared Jan 24, 1995
11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE
K931442 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 673d
Cleared Jan 24, 1995
3M MODEL 8233 HEARING INSTRUMENT
K943854 · ESD
3M Company
Ear, Nose, Throat · 169d
Cleared Jan 20, 1995
HORMANN HEARING INSTRUMENTS
K945219 · ESD
Hormann, Inc.
Ear, Nose, Throat · 86d
Cleared Jan 19, 1995
RESOUND PERSONAL HEARING SYSTEMS MODIFICATION
K934917 · ESD
Resound Corp.
Ear, Nose, Throat · 463d
Cleared Jan 19, 1995
NASAL SPLINT
K945555 · LYA
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 66d
Cleared Jan 18, 1995
SOUND SELECTOR ITE (SSI), BTE (SSB), MINI BTE( SSM)
K944980 · ESD
Hearing Solutions, Inc.
Ear, Nose, Throat · 99d
Cleared Jan 18, 1995
NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES,...
K945381 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 77d
Cleared Jan 18, 1995
PREMIER MIRROR WARMER
K945395 · ETF
Premier Dental Products Co.
Ear, Nose, Throat · 76d
Cleared Jan 18, 1995
ANTERIOR/POSTERIOR EPISTAXIS CATHETER
K945556 · EMX
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 65d
Cleared Jan 11, 1995
OLYMPUS NASAL AND SINUS ENDOSCOPES
K944072 · EOB
Olympus America, Inc.
Ear, Nose, Throat · 142d
Cleared Jan 09, 1995
STRYKER TOTAL PERFORMANCE SYSTEM
K943569 · ERL
Stryker Corp.
Ear, Nose, Throat · 171d
Cleared Jan 09, 1995
BLACKSTAR(TM) STAR SYSTEM
K945659 · ERL
Xomed-Treace, Inc.
Ear, Nose, Throat · 53d
Cleared Jan 05, 1995
SIEMENS 10A FACEPLATE WITH CIC INSTRUMENTS
K943380 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 176d
Cleared Dec 30, 1994
ORION PPM, PP, PP-D
K944777 · ESD
Rexton, Inc.
Ear, Nose, Throat · 94d
Cleared Dec 30, 1994
EMSEE LABS MODEL S
K944984 · ESD
Emsee Lab of Florida
Ear, Nose, Throat · 79d
Cleared Dec 30, 1994
EMSEE LABS MODE M
K944985 · ESD
Emsee Lab of Florida
Ear, Nose, Throat · 79d
Cleared Dec 30, 1994
EMSEE LABS MODEL C
K944986 · ESD
Emsee Lab of Florida
Ear, Nose, Throat · 79d
Cleared Dec 29, 1994
EXPRESSION RX-12, ENHANCEMENT RX-34, ELITE RX-12
K944359 · ESD
Rexton, Inc.
Ear, Nose, Throat · 113d
Cleared Dec 27, 1994
LIFESOUND MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMABLE INSTRUMENTS
K944174 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 123d