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"
793–816 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Mar 28, 2017
BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO
K161816 · MDB
bioMerieux, Inc.
Microbiology · 270d
Cleared Mar 21, 2017
Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood...
K152534 · NBW
Tianjin Empecs Medical Device Co., Ltd.
Chemistry · 564d
Cleared Mar 17, 2017
Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface
K170583 · DTN
Medtronic, Inc.
Cardiovascular · 17d
Cleared Mar 17, 2017
Consult Station TS
K153600 · DXN
H4D Sas
Cardiovascular · 457d
Cleared Mar 14, 2017
Safety Blood Collection Set
K163093 · FMI
Jiangsu Shenli Medical Production...
General Hospital · 130d
Cleared Mar 09, 2017
BGM009 Plus Blood Glucose Monitoring System
K170267 · NBW
Apex BioTechnology Corp.
Chemistry · 41d
Cleared Mar 08, 2017
INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
K161733 · DTN
Sorin Group Italia S.R.L.
Cardiovascular · 258d
Not Cleared Feb 23, 2017
Accelerate Pheno system, Accelerate Phenotest BC Kit
DEN160032 · PRH
Accelerate Diagnotics
Microbiology · 227d
Cleared Feb 21, 2017
Omron HEM-6400T-Z Wrist Blood Pressure Monitor
K163045 · DXN
Omron Healthcare, Inc.
Cardiovascular · 113d
Cleared Feb 16, 2017
TAP Blood Collection Device
K161521 · PRJ
Seventh Sense Biosystems, Inc.
Chemistry · 259d
Cleared Feb 16, 2017
AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose...
K153561 · NBW
Andon Health Co, Ltd.
Chemistry · 430d
Cleared Feb 14, 2017
Fully Automatic Electronic Blood Pressure Monitor
K162668 · DXN
Andon Health Co, Ltd.
Cardiovascular · 141d
Cleared Feb 10, 2017
Blood Pressure Monitor
K162089 · DXN
Beijing Choice Electronic Technology...
Cardiovascular · 197d
Cleared Feb 09, 2017
PIVO
K163508 · JKA
Velano Vascular
Chemistry · 57d
Cleared Feb 09, 2017
BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in...
K161810 · MDB
Becton Dickinson
Microbiology · 223d
Cleared Feb 08, 2017
Fully Automatic Electronic Blood Pressure Monitor
K162915 · DXN
Andon Health Co, Ltd.
Cardiovascular · 114d
Cleared Feb 08, 2017
Arm-Type Fully Automatic Digital Blood Pressure Monitor
K161577 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 246d
Cleared Feb 01, 2017
iHealth Wireless Blood Pressure Monitor
K162144 · DXN
Andon Health Co, Ltd.
Cardiovascular · 184d
Cleared Jan 19, 2017
Digital Automatic Wrist Blood Pressure Monitor SWBPM22 Series
K163113 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 73d
Cleared Jan 19, 2017
UniStrip1 Generic Blood Glucose Test Strips
K162430 · NBW
Ok Biotech Co., Ltd.
Chemistry · 141d
Cleared Jan 18, 2017
Quantum Workstation
K163657 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 26d
Cleared Jan 17, 2017
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
K163554 · KHE
Immunostics Inc.,
Hematology · 29d
Cleared Jan 12, 2017
Contour Next EZ Blood Glucose Monitoring System
K162336 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 143d
Cleared Jan 06, 2017
StatStrip Xpress 2 Glucose Hospital Meter System
K163490 · PZI
Nova Biomedical Corporation
Chemistry · 25d