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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91489–91512 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 12, 1997
HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS...
K973494 · DQX
Guidant Corp.
Cardiovascular · 88d
Cleared Dec 12, 1997
ADVANCE MODULAR TIBIAL COMPONENT
K973524 · JWH
Wrightmedicaltechnologyinc
Orthopedic · 86d
Cleared Dec 12, 1997
SEEMOR - DISPLAY & PROCESSING PROGRAM EXECUTING ON PERSONAL COMPUTER SYSTEM
K973653 · LLZ
Areeda Assoc., Ltd.
Radiology · 78d
Cleared Dec 12, 1997
MINXRAY HF100H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT
K973712 · IZL
Minxray, Inc.
Radiology · 74d
Cleared Dec 12, 1997
MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM,...
K973737 · HET
Richard Wolf Medical Instruments Corp.
Obstetrics & Gynecology · 73d
Cleared Dec 12, 1997
SWIFT DELIVERY PRODUCT #300
K973942 · HDB
Swift Delivery Products
Obstetrics & Gynecology · 77d
Cleared Dec 12, 1997
RETINAL CUBE
K973950 · HKI
Applied Spectral Imaging , Ltd.
Ophthalmic · 57d
Cleared Dec 12, 1997
SMART MOTORIZED VIEWER
K973965 · IXC
Smartlight, Ltd.
Radiology · 56d
Cleared Dec 12, 1997
SHAH PERMAVENT
K974007 · ETD
Exmoor Plastics , Ltd.
Ear, Nose, Throat · 52d
Cleared Dec 12, 1997
RESOUND STEALTH CIC
K974081 · ESD
Resound Corp.
Ear, Nose, Throat · 44d
Cleared Dec 12, 1997
HI-69E, HI-69N, HI-69P
K974129 · ESD
Rockwin Corp.
Ear, Nose, Throat · 39d
Cleared Dec 12, 1997
HOSPITAL'S CLAMP
K974227 · HFW
Gps
Obstetrics & Gynecology · 30d
Cleared Dec 12, 1997
HOSPITAL'S SPEC
K974228 · HIB
Gps
Obstetrics & Gynecology · 30d
Cleared Dec 12, 1997
RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER)
K974257 · ESD
Resound Corp.
Ear, Nose, Throat · 29d
Cleared Dec 12, 1997
CIRCUMCISION TRAY, CAT. NO. 70340
K974286 · HFX
Trinity Laboratories, Inc.
Obstetrics & Gynecology · 28d
Cleared Dec 12, 1997
UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)
K974338 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 12, 1997
UNITRON MODEL SOUND F/XD PROGRAMMABLE
K974339 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 12, 1997
UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTE
K974340 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 24d
Cleared Dec 12, 1997
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES COLORED
K974518 · LYY
Yty Industry (Manjung) Sdn Bhd
General Hospital · 10d
Cleared Dec 11, 1997
FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X,...
K964663 · DXC
Rmds, Inc.
Cardiovascular · 385d
Cleared Dec 11, 1997
HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM
K970078 · HIG
Davol Inc., Sub. C. R. Bard, Inc.
Obstetrics & Gynecology · 336d
Cleared Dec 11, 1997
URIDYLTRANSFERASE KIT, 50 HOUR (80-4000-13K)
K970277 · KQP
Astoria-Pacific, Inc.
Chemistry · 322d
Cleared Dec 11, 1997
IVT 0.014 PTFE-COATED TRACKWIRE
K971688 · DQX
Boston Scientific /International...
Cardiovascular · 218d
Cleared Dec 11, 1997
GREATBATCH SCIENTIFIC MR COMPATIBLE LAPAROSCOPES AND OPERATING LAPAROSCOPES
K972280 · GCJ
Wilson Greatbatch Technologies, Inc.
General & Plastic Surgery · 176d