Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
76537–76560 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 19, 2002
ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE
K020918 · KGO
Eci Medical Technologies, Inc.
General Hospital · 29d
Cleared Apr 19, 2002
ATRICURE BIPOLAR SYSTEM, MODELS ASU1, ASU2, ASU3, LHP1, LHP2, RHP1
K020919 · GEI
AtriCure, Inc.
General & Plastic Surgery · 29d
Cleared Apr 19, 2002
TEKNIQUE-HOVEROUND POWER WHEEL CHAIR
K021136 · ITI
Hoveround Corp.
Physical Medicine · 10d
Cleared Apr 19, 2002
MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS
K021213 · MAL
Boston Scientific Corp
Cardiovascular · 2d
Cleared Apr 18, 2002
VERSALAB APM
K013281 · HGM
Nicolet Biomedical
Obstetrics & Gynecology · 198d
Cleared Apr 18, 2002
BACT/ALERT FN CULTURE BOTTLE
K020815 · MDB
bioMerieux, Inc.
Microbiology · 36d
Cleared Apr 18, 2002
BACT/ALERT PF CULTURE BOTTLE
K020923 · MDB
bioMerieux, Inc.
Microbiology · 28d