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
33313–33336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 14, 2015
Cardinal Health Trochanteric IM Nail System
K150769 · HSB
Cardinalhealth
Orthopedic · 265d
Cleared Dec 14, 2015
AbStats Gateway
K150782 · DQD
Gi Logic, Inc.
Cardiovascular · 264d
Cleared Dec 14, 2015
ImmunoCAP Specific IgE
K150854 · DHB
Phadia AB
Immunology · 258d
Cleared Dec 14, 2015
OneTouch Ultra Plus Flex Blood Glucose Monitoring System
K151611 · NBW
Lifescan Europe
Chemistry · 182d
Cleared Dec 14, 2015
QuickRay HD Intraoral Sensor
K151926 · MUH
Denterprise International, Inc.
Radiology · 153d
Cleared Dec 14, 2015
Econsole1
K152172 · LLZ
DRTECH Corporation
Radiology · 132d
Cleared Dec 14, 2015
Intermediate Catheter, 105 cm, Intermediate Catheter, 115cm, Intermediate...
K152202 · DQY
Tni Manufacturing, Inc.
Cardiovascular · 130d
Cleared Dec 14, 2015
Disposable Infusion Needle, Safelock Disposable Infusion Needle
K152323 · FPA
Jiangyin Caina Technology Co., Ltd.
General Hospital · 119d
Cleared Dec 14, 2015
ViSi Mobile Monitoring System
K152341 · MWI
Sotera Wireless, Inc.
Cardiovascular · 117d
Cleared Dec 14, 2015
Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT...
K152554 · IYO
C.R. Bard, Inc.
Radiology · 97d
Cleared Dec 14, 2015
OTC12D AUTO RADIOGRAPHIC SYSTEM
K152767 · KPR
Del Medical, Inc.
Radiology · 81d
Cleared Dec 14, 2015
Endoskeleton(r) TCS System
K153122 · OVE
Titan Spine, LLC
Orthopedic · 46d
Cleared Dec 13, 2015
ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS
K150877 · GKP
Instrumentation Laboratory CO
Hematology · 256d
Cleared Dec 11, 2015
Spinal Inner Fixation System
K143013 · MNH
Changzhou Dingjian Medical Appliance...
Orthopedic · 417d
Cleared Dec 11, 2015
FIREFLY Pedicle Screw Navigation Guide
K143222 · MNI
Mighty Oak Medical, Inc.
Orthopedic · 396d
Cleared Dec 11, 2015
Panther StereoSeed
K143514 · MUJ
Prowess, Inc.
Radiology · 365d
Cleared Dec 11, 2015
Liquichek Cardiac Markers Plus Control LT
K150300 · JJY
Bio-Rad Laboratories
Chemistry · 308d
Cleared Dec 11, 2015
Medismart ( Latex Surgeon¿s Gloves powdered ) and Medismart + (Latex...
K151114 · KGO
St. Marys Rubbers Pvt, Ltd.
General Hospital · 228d
Cleared Dec 11, 2015
Mallinckrodt Oral/Nasal Tracheal Tube Cuffless, Non-DEHP, Murphy Eye
K151381 · BTR
Covidien
Anesthesiology · 203d
Cleared Dec 11, 2015
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT...
K151767 · JGS
Siemens Healthcare Diagnostics, Inc.
Chemistry · 164d
Cleared Dec 11, 2015
VariLift-L Interbody Fusion Device
K151900 · MAX
Wenzel Spine, Inc.
Orthopedic · 154d
Cleared Dec 11, 2015
Safelock Disposable Blood Collection Set, Disposable Blood Collection Set
K151991 · FPA
Jiangyin Caina Technology Co., Ltd.
General Hospital · 144d
Cleared Dec 11, 2015
MicroSpot Handpiece
K152153 · GEX
Asclepion Laser Technologies GmbH
General & Plastic Surgery · 130d
Cleared Dec 11, 2015
LC Bead LUMI
K152157 · KRD
Biocompatibles UK , Ltd.
Cardiovascular · 130d