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
75409–75432 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 23, 2002
ANNULOFLO SYSTEM, MITRAL MODEL AR700
K021051 · KRH
Sulzer Carbomedics, Inc.
Cardiovascular · 22d
Cleared Apr 22, 2002
TIP DEFLRCTING ENDOBRONCHIAL BLOCKER
K013865 · CBI
Cook, Inc.
Anesthesiology · 152d
Cleared Apr 22, 2002
MODIFICATION EZ-1 SYSTEM REPIRATORY SENSORS
K013905 · MNR
Pro-Tech Services, Inc.
Anesthesiology · 147d
Cleared Apr 22, 2002
HOMMED CENTRAL STATION
K020184 · DXN
Hommed, LLC
Cardiovascular · 94d
Cleared Apr 22, 2002
SNAP EEG MONITOR
K020218 · OLW
Nicolet Biomedical, Inc.
Neurology · 90d
Cleared Apr 22, 2002
SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP)
K020244 · KWQ
Synthes Spine
Orthopedic · 88d
Cleared Apr 22, 2002
MOTION TRACKING
K020294 · IYE
Accuray, Inc.
Radiology · 84d
Cleared Apr 22, 2002
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN...
K020397 · LON
Dade Behring, Inc.
Microbiology · 75d
Cleared Apr 22, 2002
BOND-3 ADHESIVE
K020499 · KLE
Jeneric/Pentron, Inc.
Dental · 67d
Cleared Apr 22, 2002
SONATA MICRO HYBRID COMPOSITE
K020555 · EBF
Pentron Laboratory Technologies
Dental · 61d
Cleared Apr 22, 2002
3M COMPLY 1228 GAS PLASMA INDICATOR TAPE
K020589 · JOJ
3M Company
General Hospital · 59d
Cleared Apr 22, 2002
LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529
K020610 · DIE
Bio-Rad
Chemistry · 56d
Cleared Apr 22, 2002
BIRD TBIRD VELA VENTILATOR
K020746 · CBK
Bird Products Corp.
Anesthesiology · 46d
Cleared Apr 22, 2002
DISTAL RADIUS PLATING SYSTEM
K020819 · HRS
Biomet, Inc.
Orthopedic · 40d
Cleared Apr 22, 2002
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE)
K020868 · LZA
Seal Polymer Industries Bhd.
General Hospital · 35d
Cleared Apr 22, 2002
THERMOMETER MODELS ST8631
K021048 · FLL
Z7 International
General Hospital · 21d
Cleared Apr 19, 2002
EMS ELECTROSTATIC FLITER AND HME COMBINATION
K013122 · CAH
Engineered Medical Systems
General Hospital · 212d
Cleared Apr 19, 2002
BACTEC MGIT 960 SIRE KITS
K014123 · MJA
Becton, Dickinson & CO
Microbiology · 123d
Cleared Apr 19, 2002
BLADEWORKS MICROKERATOME BLADE, MODEL 7061
K020079 · HNO
Blade Works, Inc.
Ophthalmic · 99d
Cleared Apr 19, 2002
50S TRINGA ULTRASOUND IMAGING SYSTEM
K020112 · IYO
Pie Medical
Radiology · 98d
Cleared Apr 19, 2002
XR PRIMER 2
K020303 · KLE
Kerr Dental Materials Center
Dental · 80d
Cleared Apr 19, 2002
MODIFICATION TO FETAL ASSIST
K020390 · LQK
Huntleigh Diagnostics , Ltd.
Obstetrics & Gynecology · 72d
Cleared Apr 19, 2002
QAB2A IGM ELISA KIT
K020694 · MVS
Cheshire Diagnostics , Ltd.
Immunology · 46d
Cleared Apr 19, 2002
QAB2A IGG ELISA KIT
K020695 · MSV
Cheshire Diagnostics , Ltd.
Immunology · 46d