Search FDA 510(k) Database

7,043 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
19561–19584 of 174,061
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
Cleared Dec 11, 2019
LOSPA II Knee System
K192507 · JWH
Corentec Co., Ltd.
Orthopedic · 90d
Cleared Dec 11, 2019
NemoScan
K192571 · LLZ
Software Nemotec S.L.
Radiology · 84d
Cleared Dec 11, 2019
FUJIFILM Distal Cap Models 33-40
K193123 · FDS
Fujifilm Corporation
Gastroenterology & Urology · 29d
Cleared Dec 11, 2019
HI-TORQUE InfilTrac Guide Wire Family
K193126 · DQX
Abbott Vascular
Cardiovascular · 29d
Cleared Dec 11, 2019
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test...
K193132 · LCX
Hangzhou Clongene Biotech Co., Ltd.
Chemistry · 29d
Cleared Dec 11, 2019
TSolution One Total Knee Application
K193135 · OLO
THINK Surgical, Inc.
Orthopedic · 29d
Cleared Dec 11, 2019
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files,...
K193167 · OCC
Luminex Molecular Diagnostics, Inc.
Microbiology · 26d