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
3673–3696 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Nov 08, 1978
THE VISUAL SPEECH AID
K781522 · LFA
Exeter Medical Labs, Inc.
Ear, Nose, Throat · 64d
Cleared Nov 03, 1978
TINNITUS MASKER
K781798 · KLW
Starkey Laboratories, Inc.
Ear, Nose, Throat · 11d
Cleared Oct 24, 1978
SHILEY CRICOTHYROTOMY TUBE
K781639 · EQN
Shiley, Inc.
Ear, Nose, Throat · 33d
Cleared Oct 17, 1978
SEPTAL BUTTON
K781529 · LFB
Xomed, Inc.
Ear, Nose, Throat · 42d
Cleared Oct 11, 1978
NASOSTAT
K781615 · EMX
Nasostat, Inc.
Ear, Nose, Throat · 20d
Cleared Oct 10, 1978
HEARING AID, ITE MODULAR MODEL I, II, V
K781663 · ESD
Oticon Corp.
Ear, Nose, Throat · 12d
Cleared Sep 27, 1978
PRO-MOLD, CUSTOM EAR
K781491 · EWD
Mcghan Medical Corp.
Ear, Nose, Throat · 30d
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