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
1585–1608 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
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
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