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
1609–1632 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Feb 27, 1995
KARL STORZ TELE-SCRUB
K950334 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 31d
Cleared Feb 27, 1995
OTICON/LOGIC
K950381 · ESD
Oticon, Inc.
Ear, Nose, Throat · 27d
Cleared Feb 27, 1995
KARL STORZ VISCOUS FLUID INJECTION SET
K950603 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 18d
Cleared Feb 27, 1995
OLYMPUS DISPOSABLE BIOPSY FORCEPS
K950636 · EOQ
Olympus America, Inc.
Ear, Nose, Throat · 14d
Cleared Feb 24, 1995
MATRICS IMPRESSION MATERIAL , SYSTEM
K944896 · ESD
Matrics, Inc.
Ear, Nose, Throat · 143d
Cleared Feb 24, 1995
KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS
K950338 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 28d
Cleared Feb 22, 1995
MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC
K944851 · ESD
Rexton, Inc.
Ear, Nose, Throat · 145d
Cleared Feb 21, 1995
KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES,...
K944861 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 141d
Cleared Feb 17, 1995
EPISTAXIS BALLOON CATHETER WITH PACKING
K945554 · EMX
Ultracell Medical Technologies, Inc.
Ear, Nose, Throat · 95d
Cleared Feb 17, 1995
ARGUS SINUS ENDOSCOPY INSTRUMENT SYSTEM
K946011 · EOB
Argus Medical Co., Inc.
Ear, Nose, Throat · 70d