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
43705–43728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 26, 2012
PIONEER STERNAL ASSIST IMPLANT SYSTEM
K120016 · HRS
Pioneer Surgical Technology, Inc.
Orthopedic · 205d
Cleared Jul 26, 2012
STRYKER ALL SUTURE ANCHORS
K120509 · MBI
Stryker
Orthopedic · 156d
Cleared Jul 26, 2012
CLARISCT
K120753 · OAS
Icrco, Inc.
Radiology · 135d
Cleared Jul 26, 2012
WI-FI BODY SCALE
K120896 · MNW
Andon Health Co, Ltd.
Gastroenterology & Urology · 122d
Cleared Jul 26, 2012
GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY...
K120993 · JAQ
Varian Medical Systems, Inc.
Radiology · 115d
Cleared Jul 26, 2012
CONNEX VITAL SIGNS MONITOR 6000 SERIES
K121013 · MWI
Welch Allyn, Inc.
Cardiovascular · 114d
Cleared Jul 26, 2012
NERVEVISION SOFTWARE SYSTEMS
K121075 · LLZ
3D Imaging Partners, Inc.
Radiology · 108d
Cleared Jul 26, 2012
COMPREHENSIVE REVERSE SHOULDER - E1 POLYETHYLENE CLAIMS
K121183 · PHX
Biomet Corporation
Orthopedic · 99d
Cleared CT Jul 26, 2012
CONTOUR NEXT BLOOD GLUCOSE METER
K121190 · LFR
Bayer Healthcare, LLC
Chemistry · 98d
Cleared Jul 26, 2012
CS-SERIES-FP WITH 3030+OPTION
K121293 · JAA
Omega Medical Imaging, LLC
Radiology · 87d
Cleared Jul 26, 2012
MOBILE C-ARM
K121303 · OXO
Canon Inc. -Medical Equipment Group
Radiology · 86d
Cleared Jul 26, 2012
SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM
K121512 · EWO
Bio-Logic Systems Corp.
Ear, Nose, Throat · 66d
Cleared Jul 26, 2012
AQUILION RXL
K121553 · JAK
Toshibamedical Systems Corporation
Radiology · 62d
Cleared Jul 26, 2012
E-CUBE 15
K121888 · IYO
Alpinion Medical Systems Co., Ltd.
Radiology · 28d
Cleared Jul 26, 2012
ALERE PBP2A TEST
K121905 · MYI
Alere Scarborough, Inc.
Microbiology · 27d
Cleared Jul 26, 2012
INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL...
K121909 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 27d
Cleared Jul 26, 2012
BEACON STABILIZATION SYSTEM
K121922 · NKB
Globus Medical, Inc.
Orthopedic · 24d
Cleared Jul 26, 2012
E-CUBE INNO
K121937 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 24d
Cleared Jul 26, 2012
MICROTARGETING XL STAR DRIVE SYSTEM
K121950 · HAW
FHC, Inc.
Neurology · 23d
Cleared Jul 26, 2012
SOVEREIGN SPINAL SYSTEM
K121982 · OVD
Medtronic Sofamor Danek
Orthopedic · 20d
Cleared Jul 26, 2012
ICP TRIAGEMANAGER
K122095 · DRG
Emergo Europe Consulting BV
Cardiovascular · 14d
Cleared Jul 25, 2012
COMPOTHIXO
K111465 · DZN
Kerrhawe SA
Dental · 426d
Cleared Jul 25, 2012
SENZZZZZ AWAY
K120176 · LBH
Centrix, Inc.
Dental · 187d
Cleared Jul 25, 2012
HLS UNI EVOLUTION & U-KNEETEC
K120262 · HSX
Tornier, Inc.
Orthopedic · 180d