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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,805 results
3673–3696 of 3,805
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Sep 27, 1978
BODY-WORN HEARING AID, MODEL 787PP
K781595 · ESD
Danavox, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 27, 1978
HEARING AID, MODEL 775 PP/AGC
K781596 · ESD
Danavox, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 14, 1978
HEARING AID, UNITRON MODEL 960PL
K781513 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 13d
Cleared Sep 11, 1978
HEARING AID, UNITRON MODEL 761P
K781502 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 07, 1978
RADIOEAR RE SERIES HEARING AIDS
K781458 · ESD
Radioear Corp.
Ear, Nose, Throat · 15d
Cleared Sep 07, 1978
PREAMPLIFIER MODELS 8101PI & 8102PI
K781474 · EWO
Life-Tech Instruments, Inc.
Ear, Nose, Throat · 10d
Cleared Aug 31, 1978
XOMED TRANSSPHENOIDAL HANDPIECE
K781418 · ERL
Xomed, Inc.
Ear, Nose, Throat · 15d
Cleared Aug 31, 1978
HEARING AID, UNITRON MODEL 975
K781434 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 10d
Cleared Aug 31, 1978
HEARING AID, UNITRON MODEL 958
K781439 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 13d
Cleared Aug 17, 1978
MILLARD MOUTH GAG
K780992 · KBN
Nestor Engineering Associates, Inc.
Ear, Nose, Throat · 64d
Cleared Aug 14, 1978
HEARING AID, MODEL 783DU
K781212 · ESD
Danavox, Inc.
Ear, Nose, Throat · 28d
Cleared Aug 14, 1978
VENTILATION TUBE SILI. SHEPPARD TYPE
K781257 · ETD
Xomed, Inc.
Ear, Nose, Throat · 21d
Cleared Aug 14, 1978
VENTILATION TUBE. SILI. DONALDSON TYPE
K781258 · ETD
Xomed, Inc.
Ear, Nose, Throat · 21d
Cleared Aug 14, 1978
VENTILATION TUBE TEFLON SHEPARD TYPE
K781259 · ETD
Xomed, Inc.
Ear, Nose, Throat · 21d
Cleared Aug 14, 1978
VENTILATION TUBE SILICONE PAPARELLA TYPE
K781260 · ETD
Xomed, Inc.
Ear, Nose, Throat · 21d
Cleared Aug 14, 1978
CHAIR, VESTIBULAR, ROTARY, COMPUT.
K781268 · LXV
Contraves
Ear, Nose, Throat · 21d
Cleared Aug 14, 1978
SPARTA BRONCHIAL BRUSH
K781365 · KTI
Sparta Instrument Corp.
Ear, Nose, Throat · 7d
Cleared Jul 27, 1978
ANEMOMETER, NASAL, EXETER
K781218 · ETL
Medika Corp.
Ear, Nose, Throat · 10d
Cleared Jul 17, 1978
HEARING AID, EYEGLASS
K781094 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 17d
Cleared Jul 17, 1978
HEARING AID, BEHIND THE EAR
K781095 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 17d
Cleared Jul 17, 1978
HEARING AID, EYEGLASS, B-12
K781096 · ESD
Argosy Intl. (Usa), Inc.
Ear, Nose, Throat · 17d
Cleared Jun 28, 1978
OTOSCOPE, DIAG. MODELS 20100 & 20200
K781029 · ERA
Welch Allyn, Inc.
Ear, Nose, Throat · 9d
Cleared Jun 28, 1978
HEARING AID
K781033 · ESD
Phonemics, Inc.
Ear, Nose, Throat · 9d
Cleared Jun 22, 1978
PHONIC EAR
K780936 · EPF
Hc Electronics
Ear, Nose, Throat · 14d