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
32113–32136 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 2016
EzDent-i / E2 / Prora View
K161117 · LLZ
Ewoosoft Co., Ltd.
Radiology · 23d
Cleared May 13, 2016
SonoSite iViz Ultrasound System
K161119 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 23d
Cleared May 12, 2016
Venous Assist System
K150980 · JOW
Daesung Maref Co., Ltd.
Cardiovascular · 394d
Cleared May 12, 2016
VERIFY STEAM Integrating Indicator
K152630 · JOJ
STERIS Corporation
General Hospital · 240d
Cleared May 12, 2016
ReNew Sterilization Trays(Catalog #3708 and #3709)
K152745 · KCT
Microline Surgical, Inc.
General Hospital · 232d
Cleared May 12, 2016
moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution...
K152749 · DPT
Moor Instruments, Ltd.
Cardiovascular · 232d
Cleared May 12, 2016
LSFG-NAVI
K153239 · HKI
Softcare Co., Ltd.
Ophthalmic · 185d
Cleared May 12, 2016
Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile...
K153316 · KGO
Cardinal Health, Inc.
General Hospital · 177d
Cleared May 12, 2016
Genteel Lancing Device
K153670 · FMK
Genteel, LLC
General & Plastic Surgery · 143d
Cleared May 12, 2016
Guiding Catheter
K153703 · DQY
Texasmedical Technologies, Inc.
Cardiovascular · 141d
Cleared May 12, 2016
GORE DrySeal Flex Introducer Sheath
K160254 · DYB
W.L. Gore & Associates, Inc.
Cardiovascular · 101d
Cleared May 12, 2016
Monoject Enteral Feeding Syringe with ENFit Connector
K160419 · PNR
Covidien
Gastroenterology & Urology · 86d
Cleared May 12, 2016
Laser Helmet LH40-EVO
K161046 · OAP
Theradome, Inc.
General & Plastic Surgery · 29d
Cleared May 11, 2016
Slit Lamp Microscope
K152429 · HJO
Shanghai Mediworks Precision...
Ophthalmic · 259d
Cleared May 11, 2016
Vericore Gradient Temporary Disc
K152443 · EBG
Whip Mix Corporation
Dental · 258d
Cleared May 11, 2016
Catalyst CSR Shoulder System
K152825 · KWT
Catalyst Orthoscience, LLC
Orthopedic · 225d
Cleared May 11, 2016
Biodesign Otologic Repair Graft
K161000 · KHJ
Cook Biotech Incorporated
Ear, Nose, Throat · 30d
Cleared May 10, 2016
Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek...
K152679 · PMN
Bio-Rad Laboratories
Microbiology · 235d
Cleared May 10, 2016
Vanguard XP Knee System
K153657 · MBH
Biomet, Inc.
Orthopedic · 141d
Cleared May 10, 2016
Reprocessed Livewire Steerable Diagnostic EP Catheter
K160242 · NLH
Innovative Health, LLC
Cardiovascular · 99d
Cleared May 10, 2016
Reprocessed Polaris X Steerable Diagnostic EP Catheter
K160303 · NLH
Innovative Health, LLC
Cardiovascular · 96d
Cleared May 10, 2016
FiberTak DR
K160319 · MBI
Arthrex, Inc.
Orthopedic · 95d
Cleared May 09, 2016
LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System...
K152431 · KRO
Waldemar Link GmbH & Co. KG
Orthopedic · 257d
Cleared May 09, 2016
IBS Implant System
K153350 · DZE
Innobiosurg Co., Ltd.
Dental · 171d