FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Ear, Nose, Throat ×
3,823 results
97–120 of 3,823
Search insights Median review: 65d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Jan 03, 2025
Synapsys VHIT
K242726 · GWN
Inventis S.R.L.
Ear, Nose, Throat · 115d
Cleared Dec 31, 2024
Nasal Aspirator (NS 13)
K241852 · BTA
Avita Corporation
Ear, Nose, Throat · 187d
Cleared Dec 19, 2024
Integrity V500 (Integrity, Integrity with VEMP)
K242954 · GWJ
Vivosonic, Inc.
Ear, Nose, Throat · 85d
Cleared Dec 18, 2024
FirstFit Surgical Kit
K240763 · EWL
Freudenberg Medical, LLC
Ear, Nose, Throat · 273d
Cleared Dec 13, 2024
Bioscope Neuromonitor Device
K233001 · ETN
Biosys Biyomedikal Muhendislik San....
Ear, Nose, Throat · 448d
Cleared Nov 19, 2024
Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)
K242028 · BTA
Dongguanshi Yiyingmei Technology Co.,...
Ear, Nose, Throat · 131d
Cleared Oct 29, 2024
Video Bronchoscope System
K241612 · EOQ
Hunan Vathin Medical Instrument Co.,...
Ear, Nose, Throat · 146d
Cleared Oct 23, 2024
Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C,...
K240289 · EOQ
Scivita Medical Technology Co., Ltd.
Ear, Nose, Throat · 265d
Cleared Sep 24, 2024
Ion Endoluminal System (IF 1000)
K242070 · EOQ
Intuitive Surgical, Inc.
Ear, Nose, Throat · 70d
Cleared Sep 19, 2024
MonoStereo
K234096 · EOB
Medicaltek Co., Ltd.
Ear, Nose, Throat · 268d
Not Cleared Sep 12, 2024
Hearing Aid Feature (HAF)
DEN230081 · SCR
Apple, Inc.
Ear, Nose, Throat · 283d
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