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
31489–31512 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 01, 2016
Infra-red forehead thermometer
K160999 · FLL
Hangzhou Hua'An Medical&Health...
General Hospital · 112d
Cleared Aug 01, 2016
EndyMed Contour Handpiece
K161199 · PBX
Endymed Medical, Ltd.
General & Plastic Surgery · 95d
Cleared Jul 30, 2016
Mozec NC-Rx PTCA Baloon Dilatation Catheter
K160961 · LOX
Meril Life Sciences Private Limited
Cardiovascular · 116d
Cleared Jul 30, 2016
Pirouette 035
K161427 · LIT
Arravasc Limited
Cardiovascular · 68d
Cleared Jul 29, 2016
HeatLux Pro II
K152087 · ILY
Home Skinovations , Ltd.
Physical Medicine · 368d
Cleared Jul 29, 2016
MEDINAUT Kyphoplasty System
K153296 · NDN
Imedicom Co., Ltd.
Orthopedic · 259d
Cleared Jul 29, 2016
Clip Flow
K153493 · EBF
Voco GmbH
Dental · 238d
Cleared Jul 29, 2016
Powder Free Blue Nitrile Examination Glove
K153732 · LZA
Qube Medical Product Sdn Bhd
General Hospital · 214d
Cleared Jul 29, 2016
UniStrip1 Generic Blood Glucose Test Strips
K160038 · NBW
Ok Biotech Co., Ltd.
Chemistry · 204d
Cleared Jul 29, 2016
Puritan Opti-Tranz Cary-Blair Collection and Transport System
K160082 · JSM
Puritan Medical Products, LLC
Microbiology · 196d
Cleared Jul 29, 2016
DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
K160107 · DXT
Merit Medical Systems, Inc.
Cardiovascular · 192d
Cleared Jul 29, 2016
Polux , Minerva and Atropos PTA Balloon Dilatation Catheter
K160256 · LIT
Brosmed Medical Co., Ltd.
Cardiovascular · 179d
Cleared Jul 29, 2016
The Luco Hybrid OSA Appliance
K160477 · OCO
Luco Hybrid Osa Appliance, Inc.
Dental · 161d
Cleared Jul 29, 2016
Cannulated Screw
K161058 · HWC
Miami Device Solutions, LLC
Orthopedic · 105d
Cleared Jul 29, 2016
TheraCem
K161256 · EMA
Bisco, Inc.
Dental · 86d
Cleared Jul 29, 2016
VertiForm Posterior Fixation System
K161499 · NKB
Next Orthosurgical
Orthopedic · 58d
Cleared Jul 29, 2016
Cianna Medical SAVI Scout Reflector and SAVI Scout System
K161507 · PDW
Cianna Medical, Inc.
Radiology · 58d
Cleared Jul 29, 2016
Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating,...
K161558 · GEI
Bovie Medical Corporation
General & Plastic Surgery · 53d
Cleared Jul 29, 2016
Allura Xper FD series and Allura Xper OR Table series
K161563 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 53d
Cleared Jul 29, 2016
PASS LP Spinal System
K161627 · NKB
Medicrea International SA
Orthopedic · 46d
Cleared Jul 29, 2016
CrossCath Support Catheter
K161801 · KRA
Cook Incorporated
Cardiovascular · 29d
Cleared Jul 29, 2016
2D Quantitative Analysis
K161839 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 24d
Cleared Jul 29, 2016
Bright
K161849 · OHS
Tanda Beauty Canada, Inc.
General & Plastic Surgery · 24d
Cleared Jul 28, 2016
Genesys Spine Apache® Anchored Cervical Interbody Fusion System
K152099 · OVE
Genesys Spine
Orthopedic · 366d