FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Ear, Nose, Throat ×
3,798 results
913–936 of 3,798
Search insights Median review: 64d Cleared: 100% Top manufacturer: Electone, Inc. Lead specialty: Ear, Nose, Throat
Cleared Oct 18, 2001
LORENZ LACTOSORB LARYNGOTRACHEAL RECONSTRUCTION IMPLANTS
K012409 · NHB
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 80d
Cleared Sep 21, 2001
AUDIOSCAN VERIFIT, MODEL VF-1
K012306 · ETW
Etymonic Design, Inc.
Ear, Nose, Throat · 60d
Cleared Sep 21, 2001
SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)
K012456 · ERL
Sodemsystems
Ear, Nose, Throat · 51d
Cleared Sep 13, 2001
OTO-CEM
K011338 · NEA
Ototech, Inc.
Ear, Nose, Throat · 134d
Cleared Aug 15, 2001
HADGEL, 4 GRAM/SYRINGE
K011544 · LYA
Seikagaku Corp.
Ear, Nose, Throat · 89d
Cleared Aug 10, 2001
OLYMPUS SPRAY CATHETER PW-6C-1
K012073 · EOQ
The Olympus Optical Co.
Ear, Nose, Throat · 39d
Cleared Jul 26, 2001
GSI AUDERA
K011135 · EWO
Nicolet Biomedical
Ear, Nose, Throat · 104d
Cleared Jul 25, 2001
XENF-DP RHINO-LARYNGOFIBERSCOPE, ITS ACCESSORIES AND ANCILLARY EQUIPMENT
K011869 · EOB
The Olympus Optical Co.
Ear, Nose, Throat · 41d
Cleared Jul 23, 2001
BILATERAL FITTING OF THE BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM.
K011438 · LXB
Entific Medical Systems, Inc.
Ear, Nose, Throat · 74d
Cleared Jul 18, 2001
VIVO 200 DPS VIVOSCAN
K003364 · EWO
Vivosonic, Inc.
Ear, Nose, Throat · 264d
Cleared Jul 03, 2001
HYALOMATRIX CO
K003855 · KHJ
Fidia Advanced Biopolymers Srl
Ear, Nose, Throat · 202d
Cleared Jul 03, 2001
ETYMOTIC RESEARCH ER-10D OAE PROBE
K011114 · EWO
Etymotic Research
Ear, Nose, Throat · 82d
Cleared Jun 26, 2001
MODIFICATION TO XPS 3000 SYSTEM
K011321 · ERL
Medtronic Xomed, Inc.
Ear, Nose, Throat · 60d
Cleared Jun 26, 2001
LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT
K011554 · MIX
Biomet, Inc.
Ear, Nose, Throat · 39d
Cleared Jun 25, 2001
ICS MEDICAL CHARTR OAE WITH TYMP
K011181 · EWO
Ics Medical Corp.
Ear, Nose, Throat · 68d
Cleared Jun 25, 2001
MICRODOSE CATH, MODELS 90121-201, -202, -203
K011383 · ETD
Durect Corp.
Ear, Nose, Throat · 49d
Cleared Jun 07, 2001
CUSTOM TCI (TINNITUS CONTROL INSTRUMENT)
K011364 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 34d
Cleared Jun 01, 2001
CUSTOM TCI-COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K011366 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 28d
Cleared May 25, 2001
HUMMER IV MICRODEBRIDER SYSTEM
K011381 · ERL
Stryker Instruments
Ear, Nose, Throat · 18d
Cleared May 08, 2001
EXHALE RF PROBE
K011267 · EOQ
Broncus Technologies, Inc.
Ear, Nose, Throat · 12d
Cleared Apr 26, 2001
TCI (TINNITUS CONTROL INSTRUMENT)
K003559 · KLW
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 160d
Cleared Apr 24, 2001
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
K003558 · ESD
Siemens Hearing Instruments, Inc.
Ear, Nose, Throat · 158d
Cleared Apr 20, 2001
MODIFICATION TO CAVERMAP SURGICAL AID
K010213 · ETN
Uromed Corp.
Ear, Nose, Throat · 87d
Cleared Apr 13, 2001
LACTOSORB ETHMOID STENT
K002131 · LYA
Walter Lorenz Surgical, Inc.
Ear, Nose, Throat · 273d