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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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5,555 results for "blood"
601–624 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Oct 18, 2019
Quantum Blood and Fluid Warming System
K192325 · LGZ
Life Warmer, Inc.
General Hospital · 52d
Cleared Oct 18, 2019
Synapse 3D Blood Flow Analysis
K191544 · LLZ
Fujifilm Corporation
Radiology · 129d
Cleared Oct 17, 2019
On Call Express II Blood Glucose Monitoring System
K192175 · NBW
ACON Laboratories, Inc.
Chemistry · 66d
Cleared Sep 17, 2019
Reusable NIBP Cuff
K191253 · DXQ
Shenzhen Changke Connect Electronics...
Cardiovascular · 131d
Cleared Sep 16, 2019
Full Automatic (NIBP) Blood Pressure Monitor
K190507 · DXN
Health & Life Co., Ltd.
Cardiovascular · 199d
Cleared Sep 11, 2019
CNAP Monitor
K183521 · DXN
Cnsystems Medizintechnik GmbH
Cardiovascular · 266d
Cleared Sep 06, 2019
SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes
K183574 · DPW
Huntleigh Healthcare , Ltd.
Cardiovascular · 259d
Cleared Aug 30, 2019
EV1000 Clinical Platform NI, EV1000 Clinical Platform
K192058 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Aug 28, 2019
B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T...
K182401 · MWI
Amzetta Technologies Private Limited
Cardiovascular · 358d
Cleared Aug 27, 2019
Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with...
K191077 · KFM
Medtronic, Inc.
Cardiovascular · 126d
Cleared Aug 23, 2019
Electronic Blood Pressure Monitor
K191180 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 113d
Cleared Aug 19, 2019
Blood Pressure Monitor
K190207 · DXN
Shenzhen Viatom Technology Co., Ltd.
Cardiovascular · 196d
Cleared Aug 07, 2019
Non-invasive Hemodynamic Blood Pressure Monitor
K190893 · DXN
Vita-Course Technologies Co., Ltd.
Cardiovascular · 124d
Cleared Aug 07, 2019
Revolution Centrifugal Blood Pump
K190650 · KFM
Sorin Group Italia S.R.L.
Cardiovascular · 147d
Cleared Aug 02, 2019
Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital...
K181154 · DXN
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 458d
Cleared Jul 30, 2019
Blood Collection Accessory (BUCA)
K181754 · JKA
Nsp Tech Pte, Ltd.
General Hospital · 393d
Cleared Jul 30, 2019
Blood Transfer Accessory (BTA)
K181743 · JKA
Nsp Tech Pte, Ltd.
General Hospital · 393d
Cleared Jul 29, 2019
Non-invasive blood pressure measurement systems
K190886 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 116d
Cleared Jul 22, 2019
Digital Automatic Blood Pressure Monitor MD36 Series
K191593 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 38d
Cleared Jul 10, 2019
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K190818 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 100d
Cleared Jul 09, 2019
LifeSPARC Pump, LifeSPARC Controller
K183623 · KFM
Cardiacassist, Inc.
Cardiovascular · 195d
Cleared Jul 08, 2019
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)
K190485 · JKA
Kawasumi Laboratories, Inc.
General Hospital · 131d
Cleared Jul 03, 2019
Arm-type Electronic Blood Pressure Monitor
K183058 · DXN
Shenzhen Bsx Technology Electronics...
Cardiovascular · 243d
Cleared Jun 24, 2019
Oscillometric Blood Pressure Monitor
K190927 · DXN
Rudolf Riester GmbH
Cardiovascular · 76d