Search FDA 510(k) Database

6,959 clearances indexed · Search by device name, K-number, manufacturer or product code

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174,061 results
18097–18120 of 174,061
Cleared Jun 12, 2020
Full Automatic(NIBP) Blood Pressure Monitor
K200521 · DXN
Health & Life Co., Ltd.
Cardiovascular · 102d
Cleared Jun 12, 2020
INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE...
K200683 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 88d
Cleared Jun 12, 2020
Kubtec Mozart Supra
K200756 · MWP
Kub Technologies, Inc.
Radiology · 80d
Cleared Jun 12, 2020
Hemo Control (optional Add Pack Hemo Control DM)
K200909 · GKR
Ekf Diagnostic GmbH
Hematology · 67d
Cleared Jun 12, 2020
REAL INTELLIGENCE CORI (CORI)
K201022 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 53d
Cleared Jun 12, 2020
ExpanSure Large Access Transseptal Dilator
K201288 · DRE
Baylis Medical Company, Inc.
Cardiovascular · 29d
Cleared Jun 11, 2020
uWS-MI
K192630 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 262d
Cleared Jun 11, 2020
physIQ Heart Rhythm and Respiration Module
K193415 · DPS
Physiq, Inc.
Cardiovascular · 185d
Cleared Jun 11, 2020
MEDO ARIA
K200356 · QIH
Medo.Ai
Radiology · 119d
Cleared Jun 11, 2020
E>EyeC
K200616 · ONF
E-Swin
General & Plastic Surgery · 94d
Cleared Jun 11, 2020
RIGEL 3DR Anterior Cervical Interbody Fusion System
K200685 · ODP
MiRus, LLC
Orthopedic · 87d
Cleared Jun 11, 2020
Auto 3D Bladder Volume Tool
K200980 · IYO
Butterfly Network, Inc.
Radiology · 58d
Cleared Jun 11, 2020
Versana Active
K200998 · IYN
GE Medical Systems Ultrasound and...
Radiology · 56d
Cleared Jun 11, 2020
In-Ka Ureteral Balloon Dilatation Catheter
K201007 · EZN
Coloplast Corp.
Gastroenterology & Urology · 55d
Cleared Jun 11, 2020
Gold Anchor
K201117 · IYE
Naslund Medical AB
Radiology · 45d
Cleared Jun 11, 2020
Benchmark BMX96 Access System
K201271 · DQY
Penumbra, Inc.
Neurology · 30d
Cleared Jun 10, 2020
Auxein Nailing System
K192003 · JDS
Auxein Medical Private Limited
Orthopedic · 320d
Cleared Jun 10, 2020
Naviswiss Hip Navigation System
K193094 · OLO
Naviswiss AG
Orthopedic · 216d
Cleared Jun 10, 2020
BruxZir Steel
K200131 · EIH
Prismatik Dentalcraft, Inc.
Dental · 141d
Cleared Jun 10, 2020
RayCare 3.1
K200487 · MUJ
RaySearch Laboratories AB (PUBL)
Radiology · 104d
Cleared Jun 10, 2020
SeaSpine Meridian System, SeaSpine Regatta Lateral System
K200879 · MAX
SeaSpine Orthopedics Corporation
Orthopedic · 69d
Cleared Jun 10, 2020
Hemospray Endoscopic Hemostat
K200972 · QAU
Wilson-Cook Medical, Inc.
General & Plastic Surgery · 58d
Cleared Jun 10, 2020
SR-8230, SR-8230S Portable X-ray Unit
K200976 · IZL
Shantou Institute of Ultrasonic...
Radiology · 58d
Cleared Jun 10, 2020
Intraoral Sensor
K201247 · MQB
Dentium Co., Ltd (Ict Branch)
Radiology · 30d