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
1657–1680 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Dec 27, 1994
MO4 SERIES
K944404 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 110d
Cleared Dec 27, 1994
WIDEX MODEL LOGO 8S
K944518 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 102d
Cleared Dec 27, 1994
AIR CONDUCTION HEARING AID
K944520 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 102d
Cleared Dec 27, 1994
SIEMENS FRONTIER SERICE, MODELS S-1,S-2 AND S-3 MULTIPLE SITUATION, SINGLE...
K944645 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 97d
Cleared Dec 27, 1994
NERVE MONITOR ELECTRODES/STIMULATOR PROBES
K945242 · ETN
Micromed Development Corp.
Ear, Nose, Throat · 61d
Cleared Dec 23, 1994
BEHIND THE EAR HEARING AID
K944039 · ESD
Audicraft Hearing Instruments
Ear, Nose, Throat · 127d
Cleared Dec 23, 1994
BTP-A HEARING SYSTEM
K944043 · ESD
Resound Corp.
Ear, Nose, Throat · 127d
Cleared Dec 23, 1994
WIDEX MODEL LOGO - L9
K945703 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 51d
Cleared Dec 23, 1994
IN-THE-EAR HEARING AID
K945710 · ESD
Truetone Hearing Systems, Inc.
Ear, Nose, Throat · 32d
Cleared Dec 21, 1994
DEEP CANAL HEARING INSTRUMENT
K942702 · ESD
Rexton, Inc.
Ear, Nose, Throat · 196d