FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

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5,538 results for "blood"
745–768 of 5,538
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
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
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