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"
697–720 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Aug 31, 2018
CareSens S Fit Blood Glucose Monitoring System
K180866 · NBW
I-Sens, Inc.
Chemistry · 151d
Cleared Aug 29, 2018
Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic...
K181104 · DXN
Shenzhen Combei Technology Co., Ltd.
Cardiovascular · 125d
Cleared Aug 24, 2018
EasyMax BT Self-Monitoring Blood Glucose System
K182057 · NBW
Eps Bio Technology Corp.
Chemistry · 24d
Cleared Aug 22, 2018
Non-invasive blood pressure measurement systems
K173024 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 328d
Cleared Aug 21, 2018
Confidence Blood Glucose Monitoring System
K173658 · NBW
Applied Biomedical, LLC
Chemistry · 265d
Cleared Aug 21, 2018
Reusable NIBP Cuff
K173197 · DXQ
Orantech, Inc.
Cardiovascular · 323d
Cleared Aug 20, 2018
BD Vacutainer Eclipse Signal Blood Collection Needle
K170824 · FMI
Becton, Dickinson and Company
General Hospital · 518d
Cleared Aug 17, 2018
Quantum Workstation 12.1
K181923 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 30d
Cleared Aug 17, 2018
Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose...
K173638 · NBW
Bionime Corporation
Chemistry · 266d
Cleared Aug 09, 2018
FORA GTel Blood Glucose Monitoring System
K173505 · NBW
Foracare, Inc.
Chemistry · 269d
Cleared Aug 03, 2018
Arm Type Blood Pressure Monitor
K180155 · DXN
Avita Corporation
Cardiovascular · 196d
Cleared Aug 02, 2018
Med-link Reusable Blood Pressure Cuff
K173869 · DXQ
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 225d
Cleared Jul 17, 2018
Stat Profile Prime Plus Analyzer System
K173797 · CHL
Nova Biomedical Corporation
Chemistry · 215d
Cleared Jul 12, 2018
StatStrip Glucose Hospital Meter System
K181043 · PZI
Nova Biomedical Corporation
Chemistry · 84d
Cleared Jul 12, 2018
ActiveCare TD-4121 Blood Glucose Monitoring System
K173511 · NBW
Taidoc Technology Corporation
Chemistry · 241d
Cleared Jul 05, 2018
FilmArray Blood Culture Identification (BCID) Panel
K181493 · PEN
Biofire Diagnostics, LLC
Microbiology · 29d
Cleared Jun 28, 2018
Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM
K172457 · DPW
Deltex Medical Limited
Cardiovascular · 318d
Cleared Jun 21, 2018
BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software
K173028 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 266d
Cleared Jun 19, 2018
Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose...
K173139 · NBW
Bionime Corporation
Chemistry · 263d
Cleared Jun 18, 2018
AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816,...
K172895 · DXN
Ageless Health Industrial Co., Ltd.
Cardiovascular · 269d
Cleared Jun 14, 2018
POGO Automatic Blood Glucose Monitoring System
K181316 · NBW
Intuity Medical, Inc.
Chemistry · 27d
Cleared Jun 04, 2018
Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting...
K172763 · JKA
Zhejiang Kindly Medical Devices Co.,...
General Hospital · 264d
Cleared May 30, 2018
ANEROID SPHYGMOMANOMETER
K173246 · DXQ
Wenzhou Bokang Instruments Co., Ltd.
Cardiovascular · 236d
Cleared May 24, 2018
T2Bacteria Panel
K172708 · QBX
T2biosystems, Inc.
Microbiology · 258d