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"
457–480 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Jan 28, 2022
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U,...
K212341 · DTZ
Qura S.R.L
Cardiovascular · 184d
Cleared Jan 27, 2022
RA-T59 Wrist blood pressure monitor
K212312 · DXN
Lotusnine Medical Limited
Cardiovascular · 188d
Cleared Jan 27, 2022
VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek...
K211589 · DPW
Remington Medical, Inc.
Cardiovascular · 248d
Cleared Jan 19, 2022
Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33
K211532 · DXN
Yibin Junxin Electronics Technology...
Cardiovascular · 246d
Cleared Jan 12, 2022
Arm Blood Pressure Monitor
K212877 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 125d
Cleared Jan 05, 2022
Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully...
K212115 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 182d
Cleared Dec 29, 2021
GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test...
K202101 · JPA
Accriva Diagnostics, Inc.
Hematology · 518d
Cleared Dec 23, 2021
Contour® next GEN Blood Glucose Monitoring System
K193407 · NBW
Ascensia Diabetes Care
Chemistry · 745d
Cleared Dec 17, 2021
Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood...
K203424 · DTZ
Qura S.R.L
Cardiovascular · 392d
Cleared Dec 14, 2021
Blood Collection Needles
K200932 · FMI
Vacutest Kima Srl
General Hospital · 616d
Cleared Nov 26, 2021
Tablo Cartridge
K210782 · FJK
Outset Medical, Inc.
Gastroenterology & Urology · 255d
Cleared Nov 18, 2021
Capiox iCP Centrifugal Pump
K200091 · KFM
Terumo Cardiovascular Systems...
Cardiovascular · 672d
Cleared Nov 04, 2021
Blood Collection Needle for Single Use & Blood Collection Needle with Holder...
K212019 · JKA
Jiangsu Micsafe Medical Technology...
General Hospital · 129d
Cleared Nov 04, 2021
Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B
K211288 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 190d
Cleared Nov 03, 2021
Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor
K201320 · KFM
Qura S.R.L
Cardiovascular · 534d
Cleared Nov 01, 2021
Electronic Blood Pressure Monitor
K212171 · DXN
Dongguan Kangweile Electronic...
Cardiovascular · 112d
Cleared Oct 19, 2021
Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope
K211084 · DXQ
Shanghai Caremate Medical Device Co.,...
Cardiovascular · 190d
Cleared Oct 15, 2021
Arm Blood Pressure Monitor
K210563 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 232d
Cleared Oct 15, 2021
MultiSure GK Link Blood Glucose and Ketone Monitoring System
K201880 · NBW
Apex BioTechnology Corp.
Chemistry · 465d
Cleared Oct 07, 2021
VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek...
K212065 · DPW
Remington Medical, Inc.
Cardiovascular · 97d
Cleared Oct 05, 2021
CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood...
K201394 · NBW
I-Sens, Inc.
Chemistry · 496d
Cleared Oct 01, 2021
Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09
K210139 · DXN
Edan Instruments, Inc.
Cardiovascular · 255d
Cleared Sep 23, 2021
Reusable NIBP Cuff
K211747 · DXQ
Shenzhen Coreray Technology Co., Ltd.
Cardiovascular · 108d
Cleared Sep 23, 2021
Automatic Digital Blood Pressure Monitor
K210152 · DXN
Aviche Shandong Medical Technology...
Cardiovascular · 245d