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"
745–768 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Oct 13, 2017
Electronic Blood Pressure Monitor
K170151 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 269d
Cleared Oct 10, 2017
higi Station (with Body Composition and Pan and Tilt cuff housing), higi...
K172739 · DXN
Higi Sh, LLC
Cardiovascular · 28d
Cleared Oct 06, 2017
Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood...
K170079 · NBW
Tyson Bioresearch, Inc.
Chemistry · 269d
Cleared Oct 05, 2017
InSure ONE
K170548 · KHE
Enterix, Inc.
Hematology · 223d
Cleared Oct 05, 2017
Gold AQ Blood Glucose Monitoring System
K170264 · NBW
Changsha Sinocare, Inc.
Chemistry · 251d
Cleared Sep 27, 2017
FreeStyle Precision Neo Blood Glucose Test Strips
K171941 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 91d
Cleared Sep 27, 2017
QiF Blood and Fluid Warmer
K171215 · LGZ
Quality IN Flow , Ltd.
General Hospital · 155d
Cleared Sep 20, 2017
NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)
K171822 · NBW
Biotest Medical Corporation
Chemistry · 93d
Cleared Sep 19, 2017
Medline Blood Collection Set
K170002 · FPA
Medline Industries, Inc.
General Hospital · 259d
Cleared Sep 15, 2017
WowGoHealth Blood Glucose Monitoring System
K171785 · NBW
Biotest Medical Corporation
Chemistry · 92d
Cleared Sep 15, 2017
iHealth Align Gluco-Monitoring System (BG1)
K170231 · NBW
Andon Health Co, Ltd.
Chemistry · 233d
Cleared Sep 13, 2017
AnemoCheck
K163215 · KHG
Sanguina, LLC
Hematology · 301d
Cleared Aug 30, 2017
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K170467 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 195d
Cleared Aug 17, 2017
SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0
K163339 · DPT
Spectralmd, Inc.
Cardiovascular · 262d
Cleared Aug 16, 2017
GLUCOCARD W Blood Glucose Monitoring System
K170064 · NBW
Arkray Factory, Inc.
Chemistry · 219d
Cleared Aug 08, 2017
AFIAS iFOB with AFIAS-50
K163225 · OOX
Immunostics Inc.,
Hematology · 264d
Cleared Aug 01, 2017
BP5S Wireless Blood Pressure Monitor
K171062 · DXN
Andon Health Co, Ltd.
Cardiovascular · 113d
Cleared Jul 31, 2017
Electronic Blood Pressure Monitor
K161845 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 391d
Cleared Jul 27, 2017
Fully Automatic Blood Pressure Monitor
K171282 · DXN
Andon Health Co, Ltd.
Cardiovascular · 87d
Cleared Jul 19, 2017
Dario Blood Glucose Monitoring System
K163159 · NBW
Labstyle Innovations, Ltd.
Chemistry · 251d
Cleared Jul 07, 2017
Digital Automatic Blood Pressure Monitor BPM41 Series, Digital Automatic...
K163648 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 196d
Cleared Jul 06, 2017
GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System...
K170143 · NBW
Bionime Corporation
Chemistry · 170d
Cleared Jun 22, 2017
TransFix/EDTA Vacuum Blood Collection Tubes
K162723 · GIM
Caltag Medsystems, Ltd.
Immunology · 266d
Cleared Jun 16, 2017
DORA Tubing Sets for Hemodialysis
K161582 · FJK
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 373d