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
2113–2136 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Aug 06, 1992
BTE HEARING AID OTICON MODEL: MULTIFOCUS POWER
K923388 · ESD
Oticon Corp.
Ear, Nose, Throat · 30d
Cleared Aug 06, 1992
BTE HEARING AID PERSONIC 410
K923490 · ESD
Oticon Corp.
Ear, Nose, Throat · 22d
Cleared Aug 06, 1992
BTE HEARING AID PERSONIC 425
K923491 · ESD
Oticon Corp.
Ear, Nose, Throat · 23d
Cleared Jul 30, 1992
EURION LOTOS PP HEARING AID
K923226 · ESD
Eurion Hearing Instruments
Ear, Nose, Throat · 29d
Cleared Jul 23, 1992
NASAL SEPTAL SPLINT
K921195 · LYA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 133d
Cleared Jul 23, 1992
TURBINATE NASAL SPLINT
K921202 · LYA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 133d
Cleared Jul 17, 1992
LX 150 LIGHT SOURCE
K922095 · EQH
Welch Allyn, Inc.
Ear, Nose, Throat · 73d
Cleared Jul 10, 1992
ITE, ITC, OE(OPEN), HS(HALF SHELL) HEARING AID
K922392 · ESD
A-1 Hearing Aid Lab
Ear, Nose, Throat · 51d
Cleared Jul 08, 1992
EPISTAXIS NASAL BALLOON CATHETER
K921199 · EMX
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 118d
Cleared Jul 06, 1992
A-ZILICONE
K905555 · ESD
Oticon Corp.
Ear, Nose, Throat · 573d
Cleared Jul 01, 1992
PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2
K921707 · EOB
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 82d
Cleared Jul 01, 1992
OTOSONIC ACS K
K922827 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 19d
Cleared Jun 30, 1992
#903 SILAFLEX II
K915739 · EWD
Flents Products Co., Inc.
Ear, Nose, Throat · 197d
Cleared Jun 30, 1992
WIDEX MODEL D32
K922708 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 25d
Cleared Jun 29, 1992
BIVONA-COLORADO VOICE PROSTHESIS
K915761 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 188d
Cleared Jun 10, 1992
IN THE EAR HEARING AID
K915711 · ESD
Zenith-Omni H.C., Inc.
Ear, Nose, Throat · 188d
Cleared Jun 10, 1992
BELTONE OPERA CLEARVOICE IC, ITC (IN THE CANAL)
K922301 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 26d
Cleared Jun 10, 1992
PROGRAMMABLE HEARING SYSTEM, ITE AND BTE TYPES
K922422 · ESD
Audioscience, Inc.
Ear, Nose, Throat · 20d
Cleared May 28, 1992
RLS 9100 RHINO-LARYNGEAL STROBOSCOPE
K921184 · EQL
Kay Elemetrics Corp.
Ear, Nose, Throat · 80d
Cleared May 28, 1992
9105 RIGID TELESCOPIC ENDOSCOPE
K921285 · EQL
Kay Elemetrics Corp.
Ear, Nose, Throat · 72d
Cleared May 27, 1992
OTOSONIC ACS-IC
K922224 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 15d
Cleared May 22, 1992
PHILIPS 31 SERIES IN THE EAR HEARING AID
K921463 · ESD
Philips Hearing Instruments Co.
Ear, Nose, Throat · 56d
Cleared May 18, 1992
TELEX MODEL M29 ITE CUSTOM HEARING AID
K922065 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 14d
Cleared May 18, 1992
TELEX MODEL 28A ITE CUSTOM HEARING AID
K922066 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 14d