FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
69505–69528 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 2003
MBCP
K032268 · MQV
Biomatlante
Orthopedic · 141d
Cleared Dec 11, 2003
H/S CATHETER SET
K032835 · LKF
Catheter Research, Inc.
Obstetrics & Gynecology · 91d
Cleared Dec 11, 2003
SPECTRA PULSED DIODE LASER, MODEL DR-1
K032846 · GEX
Spectragenics, Inc.
General & Plastic Surgery · 91d
Cleared Dec 11, 2003
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER,...
K033424 · DPW
Transonic Systems, Inc.
Cardiovascular · 49d
Cleared Dec 11, 2003
INFINITY GAMMAXL
K033600 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 27d
Cleared Dec 11, 2003
SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800
K033641 · DTN
Cobe Cardiovascular, Inc.
Cardiovascular · 21d
Cleared Dec 11, 2003
M2376A PHILIPS DEVICE LINK SYSTEM
K033680 · MWI
Philips Medical Systems
Cardiovascular · 17d
Cleared Dec 11, 2003
GLIDESHEATH
K033681 · DYB
Terumo Corp.
Cardiovascular · 17d
Cleared Dec 11, 2003
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K033708 · DQX
Intra Luminal Therapeutics, Inc.
Cardiovascular · 15d
Cleared Dec 11, 2003
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE...
K033714 · DTN
Dideco S.P.A.
Cardiovascular · 15d
Cleared Dec 10, 2003
TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
K031949 · DXF
Baylis Medical Co., Inc.
Cardiovascular · 169d
Cleared Dec 10, 2003
GM3 SERIES IF TENS, MODEL GM3X2IF (WHERE X IS A PARAMETER OF DIFFERENT HOUSING)
K032719 · LIH
Gemore Technology Co, Ltd.
Neurology · 99d
Cleared Dec 10, 2003
GEM-STIM TENS, MODELS GM3XY AND GM3AXY
K032720 · GZJ
Gemore Technology Co, Ltd.
Neurology · 99d
Cleared Dec 10, 2003
A-DEC SELF-CONTAINED WATER SYSTEM, MODEL 0.7 LITER BOTTLE & 2 LITER BOTTLE
K032757 · EIA
A-Dec, Inc.
Dental · 96d
Cleared Dec 10, 2003
SCORPIO LOW PROFILE TIBIAL TRAY
K032829 · JWH
Howmedica Osteonics Corp.
Orthopedic · 90d
Cleared Dec 10, 2003
MOORLDI INFRARED LASER DOPPLER IMAGER, MODEL MOORLD12-IR
K032841 · DPT
Moor Instruments, Ltd.
Cardiovascular · 90d
Cleared Dec 10, 2003
STRYKER SPINE MAPS SYSTEM
K032855 · MNH
Howmedica Osteonics
Orthopedic · 89d
Cleared Dec 10, 2003
EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT
K032953 · KLE
Pulpdent Corporation
Dental · 79d
Cleared Dec 10, 2003
TYTAN PROFESSIONAL /ECONOMY SERIES SPHYGMOMANOMETER, NO 710/NO 700
K033025 · DXN
Tytan Medical Corp.
Cardiovascular · 75d
Cleared Dec 10, 2003
C-GRAFT
K033110 · LYC
The Clinician'S Preference, LLC
Dental · 71d
Cleared Dec 10, 2003
ENDOPATH ENDOCUTTER GRAY CARTRIDGE, MODEL 6R45M/GRAY CARTRIDGE RELOAD
K033269 · OCW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 62d
Cleared Dec 10, 2003
IMMEDIATE STABILIZING IMPLANT (ISI)
K033392 · DZE
"O" Co., Inc.
Dental · 48d
Cleared Dec 10, 2003
SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006,...
K033537 · FGE
Abbott Laboratories
Gastroenterology & Urology · 30d
Cleared Dec 10, 2003
ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607
K033544 · IPF
Everyway Medical Instruments Co.,Ltd
Physical Medicine · 30d