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
1561–1584 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared May 09, 1995
NEUROSCREEN SOFTWARE FOR USE WITH THE NEUROSIGN 100 NERVE MONITOR
K951641 · ETN
The Magstim Company , Ltd.
Ear, Nose, Throat · 49d
Cleared May 03, 1995
OTOSCOPE A-34
K950788 · ERA
Neitz Instruments Company, Ltd.
Ear, Nose, Throat · 71d
Cleared May 03, 1995
THE PILOT AUDIOMETER
K951527 · EWO
American Electromedics Corp.
Ear, Nose, Throat · 30d
Cleared Apr 27, 1995
RESOUND PERSONAL HEARING SYSTEM MODELS BTP2 & BTP2/S W/REMOTE CONTROL OPTION
K951378 · ESD
Resound Corp.
Ear, Nose, Throat · 31d
Cleared Apr 27, 1995
RESOUND PERSONAL HEARING SYSTEM MODELS ED3A & ED3A/S W/REMONTE CONTROL OPTION
K951379 · ESD
Resound Corp.
Ear, Nose, Throat · 31d
Cleared Apr 17, 1995
SPECULUM, ENT (S3)
K951049 · ERA
Pedia Pals, Inc.
Ear, Nose, Throat · 42d
Cleared Apr 17, 1995
SPECULUM, ENT (S3)
K951050 · ERA
Pedia Pals, Inc.
Ear, Nose, Throat · 42d
Cleared Apr 17, 1995
INTRAARC DRIVE SYSTEM
K951263 · ERL
Linvatec Corp.
Ear, Nose, Throat · 27d
Cleared Apr 14, 1995
RESOUND PERSONAL HEARING SYSTEM BT2/S-E
K951374 · ESD
Resound Corp.
Ear, Nose, Throat · 18d
Cleared Apr 14, 1995
RESOUND PERSONAL HEARING SYSTEM ED3/S-E
K951375 · ESD
Resound Corp.
Ear, Nose, Throat · 18d
Cleared Apr 14, 1995
RESOUND PERSONAL HEARING SYSTEM BT2/S SERIES W/REMOTE CONTROL OPTION
K951376 · ESD
Resound Corp.
Ear, Nose, Throat · 18d
Cleared Apr 14, 1995
RESOUND PERSONAL HEARING SYSTEM BTP/S-A W/REMOTE CONTROL OPTION
K951377 · ESD
Resound Corp.
Ear, Nose, Throat · 18d
Cleared Apr 13, 1995
BELTONE COMPARAFIT
K946340 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 105d
Cleared Apr 13, 1995
IMEDGE VIDEO OSTOSCOPE (ANALOG)
K951255 · ERA
Introspect, Inc.
Ear, Nose, Throat · 41d
Cleared Apr 12, 1995
IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE
K950983 · ERA
Introspect, Inc.
Ear, Nose, Throat · 40d
Cleared Apr 11, 1995
RH2000 REAL EAR MEASUREMENT SYSTEM
K945199 · EWO
Madsen Electronics, Inc.
Ear, Nose, Throat · 169d
Cleared Apr 10, 1995
FB-18X, FIBER BRONCHOSCOPE
K951199 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 25d
Cleared Apr 10, 1995
CITATION SINUSCOPE
K951249 · EOB
Citation Medical Corp.
Ear, Nose, Throat · 21d
Cleared Apr 07, 1995
FNL-10P, FIBER NASOPARHYNGOSCOPE
K951196 · EOB
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 22d
Cleared Apr 06, 1995
WELCH ALLYN OTOSCOPE
K950787 · ERA
Welch Allyn, Inc.
Ear, Nose, Throat · 44d
Cleared Apr 06, 1995
KARL STORZ NASAL,, TONSIL, EAR, LARYNGEAL SNARE
K951201 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 31, 1995
SILVER ULTRA MINI CANAL
K950458 · ESD
Electone, Inc.
Ear, Nose, Throat · 56d
Cleared Mar 31, 1995
MIRACLE-EAR MODEL PBM PROGRAMMABLE HEARING AID
K950691 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 45d
Cleared Mar 31, 1995
MIRACLE-EAR MODEL PBS PROGRAMMABLE HEARING AID
K950692 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 45d