FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

5,530 results for "blood"
865–888 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Jun 24, 2016
SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor...
K153201 · NBW
Sd Biosensor
Chemistry · 233d
Cleared Jun 24, 2016
Digital Blood Pressure Monitor
K153033 · DXN
Suzhou Sunspiri Co., Ltd.
Cardiovascular · 249d
Cleared Jun 23, 2016
StatStrip Xpress Blood Glucose Monitoring System
K160156 · NBW
Nova Biomedical Corporation
Chemistry · 153d
Cleared Jun 23, 2016
QiF Blood and Fluid Warmer
K150404 · LGZ
Quality IN Flow , Ltd.
General Hospital · 491d
Cleared Jun 14, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K161156 · DXN
Health & Life Co., Ltd.
Cardiovascular · 50d
Cleared Jun 13, 2016
Medline Singe Patient Use Blood Pressure Cuff
K161035 · DXQ
Medline Industries, Inc.
Cardiovascular · 61d
Cleared Jun 07, 2016
IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood...
K153388 · FMI
Guangzhou Improve Medical Instruments...
General Hospital · 197d
Cleared Jun 01, 2016
EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System,...
K160552 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 93d
Cleared Jun 01, 2016
AGE Automatic Upper Arm Blood Pressure Monitor
K153552 · DXN
Ageless Health Industrial Co., Ltd.
Cardiovascular · 173d
Cleared May 12, 2016
Genteel Lancing Device
K153670 · FMK
Genteel, LLC
General & Plastic Surgery · 143d
Cleared May 12, 2016
moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution...
K152749 · DPT
Moor Instruments, Ltd.
Cardiovascular · 232d
Cleared May 06, 2016
Digital Blood Pressure Monitor
K152415 · DXN
Suzhou Sunspirit Co., Ltd.
Cardiovascular · 254d
Cleared May 05, 2016
PeriFlux6000
K152930 · DPW
Perimed AB
Cardiovascular · 213d
Cleared May 05, 2016
Cogent Hemodynamic Monitoring System
K152006 · DXQ
Icu Medical, Inc.
Cardiovascular · 289d
Cleared Apr 25, 2016
POGO Automatic Blood Glucose Monitoring System
K152493 · NBW
Intuity Medical, Inc.
Chemistry · 237d
Cleared Apr 22, 2016
U80 Series Upper Arm Electronic Blood Pressure Monitor
K160019 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 108d
Cleared Apr 22, 2016
CueSee Hypoxic
K152553 · JJS
Eurotrol B.V.
Chemistry · 227d
Cleared Apr 21, 2016
AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System
K152365 · NBW
Agamatrix, Inc.
Chemistry · 244d
Cleared Apr 15, 2016
CRIT-LINE III Blood Chamber II
K160749 · KOC
Fresenius Medical Care Renal...
Gastroenterology & Urology · 28d
Cleared Apr 14, 2016
Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff
K153251 · DXQ
Ningbo Free Trade Zone Tenso Medical...
Cardiovascular · 156d
Cleared Apr 13, 2016
A&D Medical TM-2657 Family of Digital Blood Pressure Monitors
K151953 · DXN
A&D Company, Ltd.
Cardiovascular · 273d
Cleared Apr 12, 2016
HealthChek Network Health Station
K152107 · DXN
Healthchek Network, LLC
Cardiovascular · 258d
Cleared Apr 01, 2016
TRUE METRIX GO Self Monitoring Blood Glucose System
K143548 · NBW
Trividia Health, Inc.
Chemistry · 473d
Cleared Mar 29, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160336 · DXN
Health & Life Co., Ltd.
Cardiovascular · 50d