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"
841–864 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Sep 26, 2016
Endophys Blood Pressure Monitor
K160945 · DSK
Endophys Holdings, LLC
Cardiovascular · 174d
Cleared Sep 23, 2016
BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube
K160657 · JKA
Becton, Dickinson and Company
Chemistry · 199d
Cleared Sep 21, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K162338 · DXN
Health & Life Co., Ltd.
Cardiovascular · 30d
Cleared Sep 02, 2016
Sysmex Automated Blood Coagulation Analyzer CS-5100
K161317 · JPA
Siemens Healthcare Diagnostics...
Hematology · 114d
Cleared Sep 01, 2016
Sysmex Automated Blood Coagulation Analyzer CS-2100i
K161312 · JPA
Siemens Healthcare Diagnostics...
Hematology · 114d
Cleared Aug 31, 2016
ACCU-CHEK Guide Blood Glucose Monitoring System
K160944 · NBW
Roche Diabetes Care, Inc.
Chemistry · 148d
Cleared Aug 25, 2016
V10
K152659 · DXN
Mediana Co., Ltd.
Cardiovascular · 343d
Cleared Aug 19, 2016
iHealth Align Gluco-Monitoring system
K153286 · NBW
Andon Health Co, Ltd.
Chemistry · 281d
Cleared Aug 19, 2016
Wireless Smart Gluco-Monitoring System
K153278 · NBW
Andon Health Co, Ltd.
Chemistry · 281d
Cleared Aug 12, 2016
Raycell Mk2
K161324 · MOT
Best Theratronics Limited
Radiology · 93d
Cleared Aug 10, 2016
Audit MicroControls Linearity DROP LQ Blood Glucose
K161874 · JJX
Aalto Scientific, Ltd.
Chemistry · 33d
Cleared Aug 10, 2016
Fully Automatic Electronic Blood Pressure Monitor
K160565 · DXN
Andon Health Co, Ltd.
Cardiovascular · 163d
Cleared Aug 08, 2016
BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a...
K161306 · MDB
Becton Dickinson
Microbiology · 90d
Cleared Aug 05, 2016
On Call Pro Blood Glucose Monitoring System
K161867 · NBW
Acon Laboratories
Chemistry · 29d
Cleared Aug 05, 2016
Triton System
K160338 · PBZ
Gauss Surgical, Inc.,
General & Plastic Surgery · 179d
Cleared Aug 04, 2016
Fully Automatic Electronic Blood Pressure Monitor
K160563 · DXN
Andon Health Co, Ltd.
Cardiovascular · 157d
Cleared Jul 29, 2016
UniStrip1 Generic Blood Glucose Test Strips
K160038 · NBW
Ok Biotech Co., Ltd.
Chemistry · 204d
Cleared Jul 20, 2016
PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood...
K152599 · NBW
Ok Biotech Co., Ltd.
Chemistry · 313d
Cleared Jul 19, 2016
ABPM 7100, Hypertension Management Software
K153557 · DXN
I.E.M. GmbH
Cardiovascular · 218d
Cleared Jul 15, 2016
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid...
K151978 · CHL
Edan Instruments, Inc.
Chemistry · 364d
Cleared Jul 06, 2016
Full Automatic (NIBP) Blood Pressure Monitor
K160557 · DXN
Health & Life Co., Ltd.
Cardiovascular · 128d
Cleared Jul 06, 2016
SunTech CT40 Spot-check Vital Signs Device
K160439 · DXN
Suntech Medical
Cardiovascular · 140d
Cleared Jun 29, 2016
BloodSTOP iX Battle Matrix
K160130 · QSY
Lifescience Plus, Inc.
General & Plastic Surgery · 161d
Cleared Jun 24, 2016
Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next...
K160430 · NBW
Ascensia Diabetes Care U.S., Inc.
Chemistry · 129d