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"
721–744 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Jan 17, 2018
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
K171247 · CDS
Epocal, Inc.
Chemistry · 264d
Cleared Jan 10, 2018
Digital Blood Pressure Monitor-Wrist Style
K171833 · DXN
Shenzhen Combei Technology Co., Ltd.
Cardiovascular · 205d
Cleared Dec 29, 2017
GEM Premier 5000
K173403 · CHL
Instrumentation Laboratory CO
Chemistry · 59d
Cleared Dec 19, 2017
Reusable Blood Pressure Cuff
K171889 · DXQ
Suzhou Minhua Medical Apparatus...
Cardiovascular · 176d
Cleared Dec 18, 2017
Automated Blood Coagulation Analyzer CS-2500
K172286 · JPA
Siemens Healthcare Diagnostic...
Hematology · 143d
Cleared Dec 15, 2017
V10
K170497 · DXN
Mediana Co., Ltd.
Cardiovascular · 301d
Cleared Dec 15, 2017
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
K170029 · KFM
International Biophysics Corporation
Cardiovascular · 345d
Cleared Dec 14, 2017
CAREline Airless Hemodialysis Blood Tubing Sets
K172238 · KOC
Fresenius Medical Care Renal...
Gastroenterology & Urology · 141d
Cleared Dec 13, 2017
NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose...
K171480 · NBW
I-Sens, Inc.
Chemistry · 208d
Cleared Dec 11, 2017
Safety Blood Collection Device for Single Use
K170276 · FMI
Gemtier Medical (Shanghai), Inc.
General Hospital · 315d
Cleared Nov 22, 2017
The Wrist-Type Fully Automatic Digital Blood Pressure Monitors
K170666 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 261d
Cleared Nov 21, 2017
Automatic Wrist Bluetooth Blood Pressure Monitor
K170545 · DXN
Truly Instrument , Ltd.
Cardiovascular · 270d
Cleared Nov 20, 2017
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K173044 · DXQ
Ningbo Albert Novosino Co., Ltd.
Cardiovascular · 53d
Cleared Nov 09, 2017
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit,...
K172458 · DRS
Smiths Medical Asd, Inc.
Cardiovascular · 87d
Cleared Nov 07, 2017
StatStrip Xpress Blood Glucose Monitoring System
K170464 · NBW
Nova Biomedical Corporation
Chemistry · 265d
Cleared Nov 06, 2017
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel...
K172712 · FMK
Gri Medical & Electronic Technology...
General & Plastic Surgery · 59d
Cleared Nov 02, 2017
PixoTest Blood Glucose Monitoring System
K163087 · NBW
Ixensor Company , Ltd.
Chemistry · 364d
Cleared Oct 27, 2017
SANGRAY
K172087 · MOT
Hitachi , Ltd.
Radiology · 108d
Cleared Oct 27, 2017
Automatic Blood Pressure Monitor Model LD-518 & LD-537
K170466 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 254d
Cleared Oct 25, 2017
Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U
K170454 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 252d
Cleared Oct 19, 2017
CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT...
K170614 · NBW
I-Sens, Inc.
Chemistry · 232d
Cleared Oct 17, 2017
SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare...
K160282 · NBW
Sd Biosensor
Chemistry · 623d
Cleared Oct 13, 2017
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y
K172498 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 56d
Cleared Oct 13, 2017
GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose...
K170241 · NBW
All Medicus Co., Ltd.
Chemistry · 260d