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
1273–1296 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jan 08, 1997
LORI HEARING AID SIMULATOR
K964080 · KHL
Lori Medical Laboratories, Inc.
Ear, Nose, Throat · 89d
Cleared Jan 02, 1997
PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K964798 · ETB
Anthony D. Prescott
Ear, Nose, Throat · 34d
Cleared Dec 26, 1996
MIRACLE-EAR OR AUDIOTONE
K964669 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 35d
Cleared Dec 23, 1996
VISION-SCIENCES MODEL B-F100 BRONCHOSCOPE WITH MODEL BS-F21 DISPOSABLE...
K963795 · EOQ
Vision-Sciences, Inc.
Ear, Nose, Throat · 91d
Cleared Dec 23, 1996
DAHLBERG K-AMP BTE
K964794 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 12, 1996
DIGIFOCUS ITE
K964683 · ESD
Oticon, Inc.
Ear, Nose, Throat · 20d
Cleared Dec 06, 1996
AHS OMEGA CONCEPT
K963877 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 71d
Cleared Dec 06, 1996
AHS OMEGA HF
K963878 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 71d
Cleared Dec 06, 1996
STARKEY TM-3, TM-5 HIGH FREQUENCY TINNITUS MASKER
K964216 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 45d
Cleared Dec 06, 1996
ARTICULAR HEARING AIDS
K964603 · ESD
Decibel Instruments, Inc.
Ear, Nose, Throat · 18d
Cleared Dec 05, 1996
IMPRESS, PERFECTA, ACU-FORM, AND ACUFIT
K963958 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 64d
Cleared Dec 04, 1996
PHONAK MICROLINK, PERSONAL FM RECEIVER
K964035 · ESD
Phonak, Inc.
Ear, Nose, Throat · 57d
Cleared Nov 27, 1996
GALILEO ENDOSCOPES
K962116 · EOB
Galileo Electro-Optics Corp.
Ear, Nose, Throat · 180d
Cleared Nov 27, 1996
PRIMOFOCUS COMPACT
K963788 · ESD
Oticon Corp.
Ear, Nose, Throat · 68d
Cleared Nov 27, 1996
AHS OMEGA K-AMP
K963875 · ESD
Authorized Hearing Systems, Inc.
Ear, Nose, Throat · 62d
Cleared Nov 27, 1996
STARKEY A-13 SEQUEL PROGRAMMABLE, A-13 K-AMP PROGRAMMABLE AIR CONDUCTION...
K964214 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 36d
Cleared Nov 27, 1996
STARKEY CUSTOM SEQUEL PROGRAMMABLE AND K AMP PROGRAMMABLE AIR CONDUCTION...
K964244 · ESD
Starkey Laboratories, Inc.
Ear, Nose, Throat · 34d
Cleared Nov 27, 1996
PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATC
K964451 · ESD
Rexton, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 27, 1996
UNITRON MODEL SOUND F/XP +4
K964502 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL SOUND F/X +4
K964503 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL ICON AOHPL +4
K964504 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL ICON AOHP +4 (ICON AOHP +4)
K964508 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL ICON AOHPD +4 (ICON AOHPD +4)
K964510 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d
Cleared Nov 27, 1996
UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)
K964511 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 19d