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"
625–648 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Mar 14, 2019
Omron Model BP7900 Blood Pressure Monitor + EKG
K182579 · DXN
Omron Healthcare, Inc.
Cardiovascular · 176d
Cleared Mar 12, 2019
Microlife Digital Blood Pressure Monitor
K183469 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 88d
Not Cleared Mar 12, 2019
Quantra Hemostasis Analyzer, QPlus Cartridge
DEN180017 · QFR
Hemosonics, LLC
Hematology · 344d
Cleared Mar 03, 2019
Electronic Blood Pressure Monitor
K182495 · DXN
Shenzhen Jumper Medical Equipment...
Cardiovascular · 173d
Cleared Mar 01, 2019
BD Vacutainer Eclipse UltraFill Blood Collection Needle
K181730 · FMI
Becton, Dickinson and Company
General Hospital · 245d
Cleared Feb 27, 2019
FlowMet-R
K182494 · DPW
Laser Associated Sciences, Inc.
Cardiovascular · 169d
Cleared Feb 14, 2019
GMC Wrist Automatic Blood Pressure Monitor
K181930 · DXN
Gmc, Inc.
Cardiovascular · 211d
Cleared Feb 13, 2019
U&U Blood Collection Sets
K181508 · FMI
U&U Medical Technology Co, Ltd.
General Hospital · 251d
Cleared Feb 12, 2019
FORA P100 Blood Pressure Monitoring System
K182934 · DXN
Taidoc Technology Corporation
Cardiovascular · 113d
Cleared Feb 11, 2019
BacT/ALERT FA Plus
K183166 · MDB
bioMerieux, Inc.
Microbiology · 88d
Cleared Feb 05, 2019
Spectra Optia Apheresis System
K183081 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 91d
Cleared Feb 01, 2019
iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+)
K181070 · NBW
Andon Health Co, Ltd.
Chemistry · 284d
Cleared Jan 28, 2019
Quantum Blood and IV Fluid Infusion Warmer
K181775 · LGZ
Life Warmer, Inc.
General Hospital · 209d
Cleared Jan 25, 2019
MiniCollect K2E K2EDTA Tubes
K182078 · JKA
Greiner Bio-One Na, Inc.
Hematology · 176d
Cleared Jan 18, 2019
Kurin PIV Blood Collection Set with High Pressure
K181895 · JKA
Kurin, Inc.
General Hospital · 186d
Cleared Jan 03, 2019
Arm Blood Pressure Monitor
K180435 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 317d
Cleared Jan 02, 2019
Raycell MK1
K181737 · MOT
Best Theratronics Limited
Radiology · 184d
Cleared Dec 21, 2018
ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel
K182690 · PEO
Genmark Diagnostics, Incorporated
Microbiology · 85d
Cleared Dec 20, 2018
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
K181663 · PAM
Genmark Diagnostics, Incorporated
Microbiology · 178d
Cleared Dec 19, 2018
VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood...
K173140 · NBW
Vivachek Laboratories, Inc.
Chemistry · 446d
Cleared Dec 18, 2018
KET-1 Blood Ketone Monitoring System
K182593 · JIN
Apex BioTechnology Corp.
Chemistry · 89d
Cleared Dec 17, 2018
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K182433 · DXQ
Shenzhen Caremed Medical Technology...
Cardiovascular · 102d
Cleared Dec 14, 2018
iCertainty
K181269 · DPW
Rfpi
General & Plastic Surgery · 214d
Cleared Dec 13, 2018
StatStrip Xpress Glucose Hospital Meter System
K182552 · PZI
Nova Biomedical Corporation
Chemistry · 87d