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
31609–31632 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 18, 2016
RI Witness Embryology Heated Plate
K160504 · MQG
Research Instruments Limited
Obstetrics & Gynecology · 145d
Cleared Jul 15, 2016
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid...
K151978 · CHL
Edan Instruments, Inc.
Chemistry · 364d
Cleared Jul 15, 2016
FDR Visionary Suite
K152294 · KPR
Shimadzu Corporation
Radiology · 337d
Cleared Jul 15, 2016
Belvedere™ Lateral Plating System
K153097 · KWQ
Neurostructures, Inc.
Orthopedic · 263d
Cleared Jul 15, 2016
Juliet® Ti
K153621 · MAX
Spineart
Orthopedic · 210d
Cleared Jul 15, 2016
Steth IO
K160016 · DQD
Stratoscientific, Inc.
Cardiovascular · 192d
Cleared Jul 15, 2016
N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
K160271 · MSH
San-M Package Co., Ltd.
General Hospital · 164d
Cleared Jul 15, 2016
Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)
K160308 · FLL
Fudakang Industrial Co., Ltd.
General Hospital · 162d
Cleared Jul 15, 2016
CAD/CAMouflage Milling Bock
K160425 · EBF
Prismatik Dentalcraft, Inc.
Dental · 150d
Cleared Jul 15, 2016
Keos Lumbar IBFD
K160631 · MAX
Keos
Orthopedic · 130d
Cleared Jul 15, 2016
myPatch-s
K160704 · DSH
Dms-Service, LLC
Cardiovascular · 123d
Cleared Jul 15, 2016
TransContinental® M Spacers and InterContinental® Plate-Spacers
K161223 · OVD
Globus Medical, Inc.
Orthopedic · 77d
Cleared Jul 15, 2016
NuVasive® VersaTie System
K161265 · OWI
Nu Vasive, Incorporated
Orthopedic · 71d
Cleared Jul 15, 2016
Ascential IBD PEEKc Spacer
K161407 · ODP
Stryker Spine
Orthopedic · 56d
Cleared Jul 15, 2016
FlexSeal Introducer Sheath with Hydrophilic Coating
K161659 · DYB
Libramedical, Inc.
Cardiovascular · 29d
Cleared Jul 15, 2016
ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal...
K161668 · JWH
Conformis, Inc.
Orthopedic · 29d
Cleared Jul 15, 2016
Threshold™ Pedicular Fixation System
K161694 · NKB
Spineology, Inc.
Orthopedic · 25d
Cleared Jul 15, 2016
Comfort Cover
K161920 · IZH
Precision Dynamics Corporation
Radiology · 2d
Cleared Jul 14, 2016
PMT Platinum Depthalon Depth Electrode
K151790 · GZL
Pmt Corporation
Neurology · 379d
Cleared Jul 14, 2016
IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR...
K153087 · GAT
Ivy Sports Medicine, LLC
General & Plastic Surgery · 262d
Cleared Jul 14, 2016
ShefaBone SCPC Resorbable Bone Graft
K153230 · LYC
The Implantech Inc./Shefabone
Dental · 251d
Cleared Jul 14, 2016
Panpac Disposable Pessary Fitting Set
K153422 · HHW
Panpac Medical Corporation
Obstetrics & Gynecology · 232d
Cleared Jul 14, 2016
Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310...
K160031 · ITI
Sunrise Medical (Us), LLC
Physical Medicine · 189d
Cleared Jul 14, 2016
Amber Mill Series and Amber Press Series
K160102 · EIH
Hass Corp.
Dental · 177d