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"
889–912 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Mar 25, 2016
Great Basin Staph ID/R Blood Culture Panel
K152470 · PAM
Great Basin Scientific, Inc.
Microbiology · 207d
Cleared Mar 18, 2016
CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless...
K151499 · DXN
Caretaker Medical, LLC
Cardiovascular · 288d
Cleared Mar 15, 2016
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
K160457 · PEN
Biofire Diagnostics, LLC
Microbiology · 25d
Cleared Mar 13, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160145 · DXN
Health & Life Co., Ltd.
Cardiovascular · 52d
Cleared Feb 25, 2016
BD BACTEC Peds Plus/F Culture Vials (plastic)
K151866 · MDB
Becton, Dickinson and Company
Microbiology · 231d
Cleared Feb 24, 2016
Oxyless Blood Tubing Set
K150304 · FJK
Oxyless, Ltd.
Gastroenterology & Urology · 383d
Cleared Feb 23, 2016
Spot Skan
K152831 · DXN
Skanray Technologies Private Limited
Cardiovascular · 147d
Cleared Feb 19, 2016
FreeStyle Precision Neo H Blood Glucose Monitoring System
K153330 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 92d
Cleared Feb 19, 2016
Oscar 2
K151520 · DXN
Suntech Medical, Inc.
Cardiovascular · 259d
Cleared Feb 18, 2016
Arm automatic blood pressure monitor
K151258 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 282d
Cleared Feb 12, 2016
BD Vacutainer UltraTouch Push Button Blood Collection Set
K153309 · JKA
Becton, Dickinson and Company
Chemistry · 87d
Cleared Feb 12, 2016
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K153077 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 112d
Cleared Feb 02, 2016
iHealth Track Blood Pressure Monitor
K160014 · DXN
Andon Health Co, Ltd.
Cardiovascular · 29d
Cleared Jan 27, 2016
StatStrip Xpress 2 Glucose Hospital Meter System
K152986 · PZI
Nova Biomedical Corporation
Chemistry · 110d
Cleared Jan 26, 2016
Sysmex Automated Blood Coagulation Analyzer CS-2100i
K151259 · JPA
Siemens Healthcare Diagnostics...
Hematology · 259d
Cleared Jan 19, 2016
Flo Trac sensor, Volume View sensor
K152980 · DRS
Edwards Lifesciences, LLC
Cardiovascular · 102d
Cleared Jan 14, 2016
Spectra Optia Apheresis System
K153601 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 11, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
K150678 · JPA
Siemens Healthcare Diagnostic...
Hematology · 301d
Cleared Jan 08, 2016
MyGlucoHealth Wireless System
K143169 · NBW
Entra Health Systems
Chemistry · 430d
Cleared Jan 07, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K153214 · DXN
Health & Life Co., Ltd.
Cardiovascular · 63d
Cleared Jan 07, 2016
TIVA¿
K152924 · JKA
Velano Vascular
Chemistry · 94d
Cleared Dec 21, 2015
Dario Blood Glucose Monitoring System
K150817 · NBW
Labstyle Innovations, Ltd.
Chemistry · 269d
Cleared Dec 17, 2015
Freestyle Freedom Blood Glucose Monitoring Sytem
K152442 · NBW
Abbott Laboratories
Chemistry · 112d
Cleared Dec 17, 2015
Bpump Blood Pressure Cuff
K151810 · DXQ
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 168d