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"
649–672 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Dec 13, 2018
StatStrip Xpress 2 Glucose Hospital Meter System
K182549 · PZI
Nova Biomedical Corporation
Chemistry · 87d
Cleared Dec 13, 2018
Accu-Chek Guide Me Blood Glucose Monitoring System
K181131 · NBW
Roche Diabetes Care
Chemistry · 227d
Cleared Dec 04, 2018
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer...
K180615 · LKN
Fresenius Kabi USA,Llc
Gastroenterology & Urology · 271d
Cleared Dec 03, 2018
Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles,...
K182146 · FMI
Sol-Millennium Medical, Inc.
General Hospital · 117d
Cleared Nov 30, 2018
EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or...
K182245 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 102d
Cleared Nov 30, 2018
Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood...
K182046 · NBW
Tyson Bioresearch, Inc.
Chemistry · 122d
Cleared Nov 30, 2018
POPS! one Blood Glucose Monitoring System
K181588 · NBW
Taidoc Technology Corporation
Chemistry · 168d
Cleared Nov 29, 2018
Tyson Bio HT100-A Blood Glucose Monitoring System
K182047 · NBW
Tyson Bioresearch, Inc.
Chemistry · 121d
Cleared Nov 28, 2018
BGM014 Blood Glucose Monitoring System
K182992 · NBW
Apex BioTechnology Corp.
Chemistry · 30d
Cleared Nov 09, 2018
HEM-6410T-ZM Wrist Blood Pressure Monitor
K182481 · DXN
Omron Healthcare, Inc.
Cardiovascular · 60d
Cleared Nov 08, 2018
Wrist Blood Pressure Monitor Model BP4350
K182166 · DXN
Omron Healthcare, Inc.
Cardiovascular · 90d
Cleared Nov 08, 2018
VAMP Plus Venous/Arterial Blood Management Protection System
K181684 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 135d
Cleared Nov 06, 2018
Finapres Nova Noninvasive Hemodynamic Monitor
K173916 · DXN
Finapres Medical Systems B.V.
Cardiovascular · 319d
Cleared Nov 02, 2018
Wrist Blood Pressure Monitor Model BP6100
K182127 · DXN
Omron Healthcare, Inc.
Cardiovascular · 88d
Cleared Nov 02, 2018
CDI Blood Parameter Monitoring System 550
K182110 · DRY
Terumo Cardiovascular Systems...
Cardiovascular · 88d
Cleared Nov 01, 2018
GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine...
K181273 · NBW
I-Sens, Inc.
Chemistry · 171d
Cleared Nov 01, 2018
Spectra Optia Apheresis System
K181049 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 195d
Cleared Oct 24, 2018
VAMP Optima closed blood sampling system
K180275 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 266d
Cleared Oct 17, 2018
Full Automatic(NIBP) Blood Pressure Monitor
K180240 · DXN
Health & Life Co., Ltd.
Cardiovascular · 261d
Cleared Oct 06, 2018
Bluetooth blood pressure monitor
K182018 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 71d
Cleared Oct 03, 2018
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose...
K181527 · NBW
ACON Laboratories, Inc.
Chemistry · 114d
Cleared Sep 28, 2018
Kawasumi Laboratories Blood Drawing Kit (BDK) System
K172957 · KSB
Kawasumi Laboratories, Inc.
General Hospital · 367d
Cleared Sep 19, 2018
Oh'Care Lite Smart Blood Glucose Monitoring System
K182286 · NBW
Osang Healthcare Co. , Ltd.
Chemistry · 27d
Cleared Aug 31, 2018
CareSens S Fit Blood Glucose Monitoring System
K180866 · NBW
I-Sens, Inc.
Chemistry · 151d