FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
18409–18432 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 2020
Lim Precision Steerable TS, Steerable Sheath, Dilator
K202226 · DYB
Keystone Heart, Ltd.
Cardiovascular · 130d
Cleared Dec 15, 2020
NEXXT MATRIXX Stand Alone ALIF System
K202230 · OVD
Nexxt Spine, LLC
Orthopedic · 130d
Cleared Dec 15, 2020
Pulsed electromagnetic field wrap
K202337 · ILX
Hi-Dow International, Inc.
Physical Medicine · 120d
Cleared Dec 15, 2020
Single-use Sterile medical laser fiber
K202601 · GEX
Realton (Suzhou) Medical Technology...
General & Plastic Surgery · 98d
Cleared Dec 15, 2020
Prefilled Syringe
K202698 · EZL
Hangzhou Primecare Medical Co., Ltd.
Gastroenterology & Urology · 90d
Cleared Dec 15, 2020
308nm Excimer UV-light Skin Therapy System
K202827 · FTC
Shenzhen Gsd Tech Co., Ltd.
General & Plastic Surgery · 82d
Cleared Dec 15, 2020
Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent...
K203383 · HGX
Philips Consumer Lifestyle -...
Obstetrics & Gynecology · 28d
Cleared Dec 15, 2020
Neocis Guidance System (NGS) with Patient Splints (EPS)
K203401 · PLV
Neocis, Inc.
Dental · 26d
Cleared Dec 14, 2020
Columbus Guidewire
K200374 · MOF
Rapid Medical , Ltd.
Neurology · 304d
Cleared Dec 14, 2020
Physica system
K201084 · MBH
Lima Corporate S.P.A.
Orthopedic · 235d
Cleared Dec 14, 2020
Sterile Hypodermic Syringe for Single Use, with/without needle,...
K201284 · FMF
Set Medikal Sanayi VE Ticaret Anonim...
General Hospital · 215d
Cleared Dec 14, 2020
Maxxi Flow Sensor
K201495 · MNR
Neurovirtual USA, Inc.
Anesthesiology · 192d
Cleared Dec 14, 2020
Medical Face Mask
K201629 · FXX
Shandong Shengquan New Material Co.,...
General Hospital · 181d
Cleared Dec 14, 2020
PlaDuo System
K201735 · GEI
ShenB Co., Ltd.
General & Plastic Surgery · 172d
Cleared Dec 14, 2020
Irrisept Wound Debridement and Cleansing System
K202222 · FQH
Irrimax Corporation
General & Plastic Surgery · 130d
Cleared Dec 14, 2020
Fingertip Pulse Oximeter
K202324 · DQA
Shenzhen Bsx Technology Electronics...
Anesthesiology · 119d
Cleared Dec 14, 2020
Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
K202467 · GDW
Fengh Medical Co., Ltd.
General & Plastic Surgery · 109d
Cleared Dec 14, 2020
Ventrax Delivery System
K202610 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 96d
Cleared Dec 14, 2020
DNA/RNA Shield Collection Tube
K202641 · QBD
Zymo Research
Microbiology · 94d
Cleared Dec 14, 2020
Javelin Tailor's Bunion Fixation System
K202657 · HRS
Nvision Biomedical Technologies, Inc.
Orthopedic · 91d
Cleared Dec 11, 2020
NOVA Lite DAPI dsDNA Crithidia luciliae Kit
K192916 · KTL
Inova Diagnostics, Inc.
Immunology · 423d
Cleared Dec 11, 2020
BeamSite
K200940 · IYE
Doseoptics, LLC
Radiology · 247d
Cleared Dec 11, 2020
3M Attest Rapid Readout Biological Indicator
K200996 · FRC
3M Company
General Hospital · 239d
Cleared Dec 11, 2020
Automated ankle brachial pressure index measuring device, MESI mTABLET system
K201046 · JOM
Mesi D.O.O.; Mesi, Development of...
Cardiovascular · 234d