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
1609–1632 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
Cleared Feb 17, 1995
EXPANDACELL NASAL PACK WITH AIRWAY
K950024 · EMX
Shippert Medical Technologies Corp.
Ear, Nose, Throat · 44d
Cleared Feb 09, 1995
MINIMUFFS
K935160 · EWE
Natus Medical, Inc.
Ear, Nose, Throat · 468d
Cleared Feb 09, 1995
KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES
K946148 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 55d
Cleared Feb 08, 1995
MAGIC EAR, ELAIN
K942107 · ESD
Novaplex, Inc.
Ear, Nose, Throat · 282d
Cleared Feb 08, 1995
GAME AUDIOMETERY WORD IDENTIFICATION AUDIOMETRY FOR USE WITH PRODIGIT(TM)...
K945689 · EWO
Calmed Technology, Inc.
Ear, Nose, Throat · 79d
Cleared Feb 08, 1995
VIP
K950080 · ESD
Bell Hearing Instruments, Inc.
Ear, Nose, Throat · 29d
Cleared Feb 08, 1995
RESOUND(R) PERSONAL HEARING SYSTEM ED-3 ENCORE
K950319 · ESD
Resound Corp.
Ear, Nose, Throat · 13d
Cleared Feb 07, 1995
VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID})
K944671 · EOB
Jedmed Instrument Co.
Ear, Nose, Throat · 138d
Cleared Feb 02, 1995
JARIT RECOMMENDED SINUS INSTRUMENTS
K944670 · EOB
J. Jamner Surgical Instruments, Inc.
Ear, Nose, Throat · 133d
Cleared Feb 02, 1995
VOYAGER 522
K945032 · EWO
Madsen Electronics, Inc.
Ear, Nose, Throat · 112d
Cleared Jan 30, 1995
OTICON
K946045 · ESD
Oticon, Inc.
Ear, Nose, Throat · 49d
Cleared Jan 30, 1995
LX-ITC
K946071 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 119d
Cleared Jan 30, 1995
MAICO IN-THE-EAR MODEL RD 201
K946253 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 38d
Cleared Jan 30, 1995
UNITRON MODEL VISTA 1000 SIGMA, AIR CONDUCTION HEARING AID
K946323 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 32d