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"
817–840 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Dec 23, 2016
Kurin Blood Culture Collection Set
K162233 · JKA
Pathway, LLC
Chemistry · 137d
Cleared Dec 23, 2016
BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring...
K161299 · NBW
Apex BioTechnology Corp.
Chemistry · 228d
Cleared Dec 16, 2016
NoCoding1 Plus Blood Glucose Monitoring System
K160742 · NBW
I-Sens, Inc.
Chemistry · 274d
Cleared Dec 14, 2016
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
K160412 · CHL
Instrumentation Laboratory CO
Chemistry · 306d
Cleared Dec 12, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
K162420 · JPA
Siemens Healthcare Diagnostics...
Hematology · 104d
Cleared Nov 30, 2016
One Drop Blood Glucose Monitoring System
K161834 · NBW
Agamatrix, Inc.
Chemistry · 148d
Cleared Nov 28, 2016
VAMP Venous/Arterial Blood Management Protection System
K161962 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 133d
Cleared Nov 28, 2016
Med-link Reusable Blood Pressure Cuff, Med-link Disposable Blood Pressure Cuff
K160530 · DXQ
Shenzhen Med-Link Electronics Tech...
Cardiovascular · 277d
Cleared Nov 23, 2016
AMICUS Separator System, AMICUS Separator System
K162462 · GKT
Fresenius Kabi USA,Llc
Hematology · 82d
Cleared Nov 22, 2016
Evolv Model BP7000 Upper Arm Blood Pressure Monitor
K162092 · DXN
Omron Healthcare, Inc.
Cardiovascular · 117d
Cleared Nov 22, 2016
Arm automatic blood pressure monitor
K161708 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 154d
Cleared Nov 22, 2016
Compass Cast and MAP
K161408 · DRS
Centurion Medical Products Corporation
Cardiovascular · 186d
Cleared Nov 18, 2016
Fully Automatic Electronic Blood Pressure Monitor
K162230 · DXN
Adon Health Co., Ltd.
Cardiovascular · 102d
Cleared Nov 17, 2016
Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6)...
K162843 · DWB
Terumo Cardiovascular Systems...
Cardiovascular · 37d
Cleared Nov 17, 2016
CONTOUR NEXT ONE Blood Glucose Monitoring System
K160682 · NBW
Ascensia Diabetes Care
Chemistry · 252d
Cleared Nov 15, 2016
StatStrip Xpress Glucose Hospital Meter System
K161856 · PZI
Nova Biomedical Corporation
Chemistry · 132d
Cleared Nov 10, 2016
FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone...
K161738 · NBW
Taidoc Technology Corporation
Chemistry · 140d
Cleared Nov 04, 2016
ABL90 FLEX PLUS
K160153 · CHL
Radiometer Medical Aps
Chemistry · 287d
Cleared Nov 03, 2016
Electronic Sphygmomanometer
K160349 · DXN
Guangdong Biolight Meditech Co., Ltd.
Cardiovascular · 269d
Cleared Oct 31, 2016
BreathID Hp Lab System
K162150 · MSQ
Exalenz Bioscience , Ltd.
Microbiology · 90d
Cleared Oct 31, 2016
Disposable Pressure Transducer
K152472 · DRS
Zhejiang Haisheng Medical Device Co.,...
Cardiovascular · 427d
Cleared Oct 24, 2016
Automatic Arm Bluetooth Blood Pressure Monitor
K161846 · DXN
Truly Instrument Limited
Cardiovascular · 111d
Cleared Oct 14, 2016
Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure...
K161886 · DXN
Guangdong Transtek Medical...
Cardiovascular · 95d
Cleared Sep 28, 2016
BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood...
K160365 · NBW
Infopia Co, Ltd.
Chemistry · 232d