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
1585–1608 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Mar 31, 1995
MIRACLE-EAR MODEL PM1/PM2 PROGRAMMABLE HEARING AID
K950693 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 45d
Cleared Mar 31, 1995
UNITRON MODEL ESTEEM
K950759 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 42d
Cleared Mar 31, 1995
KARL STORZ STENT APPLICATOR FORCEPS
K950965 · EOQ
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 29d
Cleared Mar 24, 1995
ENDOSCOPE SHEATH
K940028 · EOB
Xomed-Treace, Inc.
Ear, Nose, Throat · 445d
Cleared Mar 24, 1995
GOLD K AMP ULTRA MINI CANAL
K950459 · ESD
Electone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 24, 1995
GOLD CD ULTRA MINI CANAL
K950460 · ESD
Electone, Inc.
Ear, Nose, Throat · 49d
Cleared Mar 24, 1995
KARL STORZ INTRA-HANDPIECES AND ACCESSORIES
K950964 · ERL
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 22d
Cleared Mar 24, 1995
RITE-BITE BIOPSY FORCEPS
K951051 · EOQ
Mill-Rose Laboratory
Ear, Nose, Throat · 18d
Cleared Mar 21, 1995
M-29 PP-PC, M-29 PP-O/PC
K950451 · ESD
Rexton, Inc.
Ear, Nose, Throat · 46d
Cleared Mar 21, 1995
MAICO IN-THE-EAR MODEL RD-312 CIC
K950637 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 36d
Cleared Mar 21, 1995
DYNA 231X
K950758 · ESD
Phonak, Inc.
Ear, Nose, Throat · 32d
Cleared Mar 21, 1995
SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY
K950888 · EWO
Calmed Technology, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 21, 1995
MEGA-SIL A-B
K950912 · ESD
Microsonic, Inc.
Ear, Nose, Throat · 22d
Cleared Mar 21, 1995
HAPEX MALLEABLE TORP
K950927 · ETA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 20d
Cleared Mar 15, 1995
HAPEX MALLEABLE PORP
K950885 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 15, 1995
HAPEX PORP
K950886 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 15, 1995
HAPEX INCUS
K950887 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 15d
Cleared Mar 15, 1995
HAPES MALLEABLE INCUS STAPES
K950984 · ETB
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 12d
Cleared Mar 14, 1995
TYMPANOSTOMY (VENTILATION) TUBE
K941407 · ETD
Xomed-Treace, Inc.
Ear, Nose, Throat · 356d
Cleared Mar 08, 1995
H5000, H5000L, H5000L REVERSE MODEL H5000C, H5000CG
K946043 · ERA
Rudolf Riester GmbH & Co. KG
Ear, Nose, Throat · 86d
Cleared Mar 07, 1995
RESOUND(R) RESOURCE(TM)
K945750 · ESD
Resound Corp.
Ear, Nose, Throat · 104d
Cleared Mar 06, 1995
TRANSTYMPANIC ENDOSCOPE
K945081 · EOB
Endooptiks, Inc.
Ear, Nose, Throat · 140d
Cleared Mar 06, 1995
OLYMPUS BIOPSY FORCEPS MODEL FB-44
K950786 · EOQ
Olympus America, Inc.
Ear, Nose, Throat · 13d
Cleared Mar 02, 1995
KARL STORZ BOUGIES, SOUNDS, DILATORS
K946331 · EOX
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 63d