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
21313–21336 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 13, 2019
VaPro Plus Pocket, VaPro Plus
K193148 · GBM
Hollister Incorporated
Gastroenterology & Urology · 30d
Cleared Dec 13, 2019
EPi-Sense Guided Coagulation System with VisiTrax
K193162 · OCL
AtriCure, Inc.
Cardiovascular · 28d
Cleared Dec 13, 2019
Deep Learning Image Reconstruction
K193170 · JAK
Ge Healthcare Japan Corporation
Radiology · 28d
Cleared Dec 13, 2019
CareView 1800Le
K193173 · MQB
Careray Digital Medical System Co., Ltd.
Radiology · 25d
Cleared Dec 13, 2019
CrossTorq 14 Guidewire
K193194 · DQX
Scientia Cardio Access, LLC
Cardiovascular · 24d
Cleared Dec 13, 2019
EXALT Model D Single-Use Duodenoscope, EXALT Controller
K193202 · FDT
Boston Scientific Corporation
Gastroenterology & Urology · 23d
Cleared Dec 13, 2019
CoreLite X-Ray Specimen Cabinet
K193317 · MWP
Cirdan Imaging Limited
Radiology · 14d
Cleared Dec 13, 2019
Tri-Ex Extraction Balloon with Multiple Sizing
K193344 · GCA
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 10d
Cleared Dec 12, 2019
Genesys Spine 3DP Lumbar Interbody System
K182987 · MAX
Genesys Spine
Orthopedic · 409d
Cleared Dec 12, 2019
BIO-C Sealer Ion+
K190537 · KIF
Angelus Industria DE Produtos...
Dental · 283d
Cleared Dec 12, 2019
Health Expert Electronic Stimulator
K190673 · NUH
Shenzhen Osto Technology Company Limited
Neurology · 272d
Cleared Dec 12, 2019
Tablo Hemodialysis System, Tablo Cartridge
K190793 · KDI
Outset Medical, Inc.
Gastroenterology & Urology · 259d
Cleared Dec 12, 2019
Lumax Guiding Catheter
K191163 · DQY
Cook Incorporated
Cardiovascular · 225d
Cleared Dec 12, 2019
OptoMonitor
K192340 · DXO
Opsens, Inc.
Cardiovascular · 106d
Cleared Dec 12, 2019
HS50/HS60 Diagnostics Ultrasound System
K192505 · IYN
Samsung Medison Co., Ltd.
Radiology · 91d
Cleared Dec 12, 2019
Invictus™ Spinal Fixation System
K192938 · NKB
Alphatec Spine, Inc.
Orthopedic · 55d
Cleared Dec 12, 2019
Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino...
K193133 · JOH
Cook Incorporated
Anesthesiology · 30d
Cleared Dec 12, 2019
Arthrex 3.9mm Corkscrew Suture Anchor
K193157 · MAI
Arthrex, Inc.
Orthopedic · 28d
Cleared Dec 11, 2019
Endotracheal Tube with Evacuation Lumen
K182739 · BTR
Well Lead Medical Co., Ltd.
Anesthesiology · 439d
Cleared Dec 11, 2019
EVO 450 series High Speed Handpieces
K190508 · EFB
Ttbio Corp.
Dental · 285d
Cleared Dec 11, 2019
Exciplex
K191086 · FTC
Clarteis
General & Plastic Surgery · 231d
Cleared Dec 11, 2019
SleepTight Mouthpiece STZ
K191618 · LRK
Michael D Williams Dds PA
Dental · 176d
Cleared Dec 11, 2019
Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter
K191880 · DRF
Innovative Health, LLC
Cardiovascular · 149d
Cleared Dec 11, 2019
MIS Dental Implant System
K192149 · DZE
Dentsply Sirona, Inc.
Dental · 124d