FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
32737–32760 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Dec 11, 2015
MotoBand¿ CP Implant System
K152306 · HRS
Crossroads Extremity Systems, LLC
Orthopedic · 119d
Cleared Dec 11, 2015
VINTAGE Art LF
K152451 · EIH
Shofu Dental Corporation
Dental · 105d
Cleared Dec 11, 2015
GORE SYNECOR Biomaterial
K152609 · FTL
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 88d
Cleared Dec 11, 2015
DR 600
K152639 · MQB
Agfa Healthcare N.V.
Radiology · 87d
Cleared Dec 11, 2015
ORTHOLOC® 3Di Foot Plating Reconstruction System
K152974 · HRS
Wrightmedicaltechnologyinc
Orthopedic · 64d
Cleared Dec 11, 2015
Xenco Medical Cervical Interbody System, Xenco Medical Lumbar Interbody System
K152987 · ODP
Xenco Medical, LLC
Orthopedic · 59d
Cleared Dec 11, 2015
iViewDose R1.0
K153011 · IYE
Elekta Limited
Radiology · 58d
Cleared Dec 11, 2015
AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced...
K153088 · PCU
Boston Scientific Corporation
Gastroenterology & Urology · 46d
Cleared Dec 11, 2015
BD FlowSmart Set, MiniMed Pro-Set
K153257 · FPA
Becton, Dickinson and Company
General Hospital · 31d
Cleared Dec 11, 2015
SpeedLock Knotless Fixation System
K153313 · MBI
ArthroCare Corporation
Orthopedic · 24d
Cleared Dec 11, 2015
Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm,...
K153461 · KNT
Maquet Critical Care AB
Gastroenterology & Urology · 10d
Cleared Dec 10, 2015
OneQ-SL Implant System
K142313 · DZE
Dentis Co., Ltd.
Dental · 478d
Cleared Dec 10, 2015
Regenomer® Syringe, Regenomer® Plug, Regenomer® Block
K150079 · NPM
Nibec Co., Ltd.
Dental · 329d
Cleared Dec 10, 2015
PAPAYA 3D Plus
K150354 · OAS
Genoray Co., Ltd.
Radiology · 302d