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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
47809–47832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 05, 2011
INTEGRITY SPINAL CARE SYSTEM
K103248 · ITH
Integra Life Sciences
Physical Medicine · 153d
Cleared Apr 05, 2011
QUICKDRAW CONVERTIBLE FIXATION IMPLANT SYSTEM
K103262 · MBI
Tornier, Inc.
Orthopedic · 152d
Cleared Apr 05, 2011
RT200
K103370 · GZI
Restorative Therapies, Inc.
Neurology · 139d
Cleared Apr 05, 2011
CUTERA GENESISPLUS LASER SYSTEM
K103626 · PDZ
Cutera, Inc.
General & Plastic Surgery · 116d
Cleared Apr 05, 2011
REVERSE MEDICAL REFLEX GUIDE CATHETER
K110055 · DQY
Reverse Medical Corporation
Cardiovascular · 85d
Cleared Apr 05, 2011
ESTELITE COLOR
K110178 · EBF
Tokuyama Dental Corporation
Dental · 74d
Cleared Apr 05, 2011
SHARPS CONTAINER
K110262 · MMK
Noble Marketing
General Hospital · 67d
Cleared Apr 05, 2011
IMPRESSION COMPOUND
K110378 · ELW
Spofadental
Dental · 83d
Cleared Apr 04, 2011
EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
K101088 · CIX
Medica Corp.
Chemistry · 350d
Cleared Apr 04, 2011
CARDIOHELP SYSTEM
K102726 · DTQ
Maquet Cardiopulmonary, AG
Cardiovascular · 195d
Cleared Apr 04, 2011
BRAINLAB KNEE
K102990 · OLO
Brainlab AG
Orthopedic · 178d
Cleared Apr 04, 2011
RT600
K103366 · GZI
Restorative Therapies, Inc.
Neurology · 139d
Cleared Apr 04, 2011
VAULT ALIF SYSTEM
K103369 · OVD
Spinal USA
Orthopedic · 138d
Cleared CT Apr 04, 2011
THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
K103428 · ONA
Restoration Robotics, Inc.
General & Plastic Surgery · 133d
Cleared Apr 04, 2011
DIGITAL FOREHEAD THERMOMETER
K103617 · FLL
K-Jump Health Co., Ltd.
General Hospital · 115d
Cleared Apr 04, 2011
KNEEALIGN SYSTEM
K103829 · OLO
Orthalign, Inc.
Orthopedic · 95d
Cleared Apr 04, 2011
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K110185 · LZA
Tangshan Baojie Glove Co., Ltd.
General Hospital · 73d
Cleared Apr 04, 2011
SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM
K110255 · QPB
Sound Surgical Technologies, LLC
General & Plastic Surgery · 66d
Cleared Apr 04, 2011
MODIFIED HD GUIDE CATHETER
K110483 · DQY
Concentric Medical, Inc.
Cardiovascular · 45d
Cleared Apr 01, 2011
CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01
K100714 · KPS
Cedars-Sinai Medical Center
Radiology · 385d
Cleared Apr 01, 2011
OSSEOTITE II MODEL XIFOSSXXX
K100724 · DZE
Biomet 3i, Inc.
Dental · 382d
Cleared Apr 01, 2011
COMPRESSYN BAND
K101484 · JDQ
Dallen Medical
Orthopedic · 308d
Cleared Apr 01, 2011
ALYTE Y-MESH GRAFT
K101722 · OTO
C.R. Bard, Inc.
Obstetrics & Gynecology · 287d
Cleared Apr 01, 2011
ARCHITECT IGENTAMICIN REAGENTS
K102699 · LCD
Abbott Laboratories
Toxicology · 193d