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
31921–31944 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 08, 2016
Sony IP Converter NU-IP40S
K161122 · GCJ
Sony Electronics, Inc.
General & Plastic Surgery · 48d
Cleared Jun 07, 2016
X-VIEW, IMAGEN
K151137 · OAS
Edlen Imaging, LLC
Radiology · 405d
Cleared Jun 07, 2016
Smart Set
K151250 · FPA
Top Spins, Inc.
General Hospital · 392d
Cleared Jun 07, 2016
A Plus Internal Fixture System
K152786 · DZE
T-Plus Implant Tech. Co., Ltd.
Dental · 256d
Cleared Jun 07, 2016
SureFine Pen Needle
K152877 · FMI
Shina Med Corporation
General Hospital · 251d
Cleared Jun 07, 2016
IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood...
K153388 · FMI
Guangzhou Improve Medical Instruments...
General Hospital · 197d
Cleared Jun 07, 2016
Getinge Series Warming Cabinet
K153713 · LHC
Getinge Sourcing, LLC
General Hospital · 166d
Cleared Jun 07, 2016
Contact Lens Case (multiple brand name)
K160005 · LRX
Danyang Chanxin Glasses Cases Factory
Ophthalmic · 155d
Cleared Jun 07, 2016
Disposable Barrier Sleeves and Covers
K160232 · PEM
Dentsply International, Inc.
Dental · 127d
Cleared Jun 07, 2016
DSM Biomedical Porcine Pericardium Dental Membrane
K160474 · NPL
Kensey Nash Corporation Dba Dsm...
Dental · 109d
Cleared Jun 07, 2016
EndoCure Model EUR078A
K161147 · FBN
Endocure Technologies, Inc.
Gastroenterology & Urology · 46d
Cleared Jun 07, 2016
Beta-2-Microglobulin
K161297 · JZG
Beckman Coulter Ireland, Inc.
Immunology · 29d
Cleared Jun 06, 2016
ORAL BOND
K142130 · EMA
Steiner Laboratories
Dental · 672d
Cleared Jun 06, 2016
NMI DUAL PORT II
K151239 · LJT
Navilyst Medical, Inc.
General Hospital · 392d
Cleared Jun 06, 2016
MICROPERIMETER MP-3
K152729 · HKI
Nidek Co., Ltd.
Ophthalmic · 258d
Cleared Jun 06, 2016
LATERAL Spine Truss System
K153436 · MAX
4Web, Inc.
Orthopedic · 192d
Cleared Jun 06, 2016
NobelProcera HT ML Full Contour Zirconia Crown
K153534 · ELL
Nobel Biocare AB
Dental · 180d
Cleared Jun 03, 2016
Wing Smart FEVI and Peak Flow Meter
K152276 · BZH
Sparo, Inc.
Anesthesiology · 296d
Cleared Jun 03, 2016
Background Pattern Classification [BPc(TM)]
K152301 · OMA
Natus Medical Incorporated Dba...
Neurology · 294d
Cleared Jun 03, 2016
Seal Rite Non-Rebreathing Valve
K152521 · CBP
The Lifeguard Store, Inc.
Anesthesiology · 274d
Cleared Jun 03, 2016
Communicator Surgical Facemask with Clear Window
K152561 · FXX
Prestige Ameritech , Ltd.
General Hospital · 268d
Cleared Jun 03, 2016
Corin Optimized Positioning System (OPS)
K152893 · LZO
Corin USA
Orthopedic · 247d
Cleared Jun 03, 2016
VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
K152961 · GGN
Maine Standards Company, LLC
Hematology · 240d
Cleared Jun 03, 2016
Disposable Concentric Needle electrodes, Disposable Monopolar Needle...
K152984 · IKT
Bio Protech, Inc.
Neurology · 238d