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
97–120 of 3,812
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jul 10, 2024
Lightin System, Lightin, Lightin Generator
K232177 · SBS
Solmedix Co., Ltd.
Ear, Nose, Throat · 352d
Cleared Jul 10, 2024
Sentio Ti Implant Kit
K240614 · PFO
Oticon Medical AB
Ear, Nose, Throat · 127d
Cleared Jul 01, 2024
Electric nasal aspirator (HTD2601US)
K241202 · BTA
Hetaida Technology Co., Ltd.
Ear, Nose, Throat · 62d
Cleared Jun 21, 2024
OtoNova/OtoNova Pro
K234095 · EWO
Otodynamics
Ear, Nose, Throat · 178d
Cleared May 24, 2024
Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6)
K232646 · KHJ
Cook Biotech Incorporated
Ear, Nose, Throat · 268d
Cleared May 20, 2024
Solo+ Tympanostomy Tube Device (TTD)
K232702 · ETD
Aventamed Dac
Ear, Nose, Throat · 258d
Cleared May 03, 2024
Silk Voice (SMI-04)
K240919 · MIX
Sofregen Medical
Ear, Nose, Throat · 30d
Cleared May 01, 2024
MiiS Horus Bronchoscope
K234113 · EOQ
Medimaging Integrated Solution, Inc...
Ear, Nose, Throat · 126d
Cleared Apr 26, 2024
Rhinolaryngoscope system
K232435 · EOB
Shenzhen HugeMed Medical Technical...
Ear, Nose, Throat · 256d
Cleared Apr 18, 2024
Cochlear Osia System
K240155 · PFO
Cochlear Americas
Ear, Nose, Throat · 90d
Cleared Apr 11, 2024
Lyric4 Hearing Aid
K232999 · ESD
Sonova AG
Ear, Nose, Throat · 202d
Cleared Apr 05, 2024
LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C,...
K233779 · EOQ
MacroLux Medical Technology Co., Ltd.
Ear, Nose, Throat · 130d
Cleared Apr 03, 2024
Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000)
K240135 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 76d
Cleared Mar 22, 2024
SeptAlign
K233569 · NHB
Spirair, Inc.
Ear, Nose, Throat · 137d
Cleared Mar 20, 2024
Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008,...
K233901 · BTA
Shenzhen Desida Technology Co., Ltd.
Ear, Nose, Throat · 100d
Cleared Mar 15, 2024
Concha Sol Hearing Aids (CL-1001)
K233747 · QUH
Concha Labs
Ear, Nose, Throat · 114d
Cleared Mar 15, 2024
Otoport Pro
K240430 · EWO
Otodynamics, Ltd.
Ear, Nose, Throat · 30d
Cleared Mar 14, 2024
hekaDrill
K233958 · ERL
Zethon, Ltd.
Ear, Nose, Throat · 90d
Cleared Mar 08, 2024
ALGO Pro Newborn Hearing Screener (ALGO Pro)
K233649 · GWJ
Natus Medical Incorporated Dba...
Ear, Nose, Throat · 115d
Cleared Feb 27, 2024
Peace N Quiet (0.7.0)
K233435 · KLW
Pnq Health
Ear, Nose, Throat · 137d
Cleared Feb 16, 2024
Biowy Tym Tube (TT)
K233658 · ETD
Biowy Corporation
Ear, Nose, Throat · 93d
Cleared Feb 15, 2024
Bronchoscope System
K231107 · EOQ
Hunan Endoso Life Technology Co., Ltd.
Ear, Nose, Throat · 302d
Cleared Feb 09, 2024
WSA Self-Fitting Hearing Aid Gen 2
K233464 · QUH
Wsaud A/S
Ear, Nose, Throat · 109d
Cleared Feb 07, 2024
FUJIFILM Endoscope Model EB-710XT
K240075 · EOQ
Fujifilm Healthcare Americas Corporation
Ear, Nose, Throat · 28d