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"
937–960 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Oct 13, 2015
Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose...
K140325 · NBW
Joinsoon Medical Technology Co, Ltd.
Chemistry · 610d
Cleared Oct 02, 2015
GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE...
K141656 · NBW
Philosys, Inc.
Chemistry · 469d
Cleared Sep 30, 2015
FreeStyle Precision Neo Blood Glucose Monitoring System
K142928 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 356d
Cleared Sep 29, 2015
Digital Automatic Blood Pressure Monitor BPM30 and BPM31 Series
K152483 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 29d
Cleared Sep 29, 2015
SureSigns VS3, SureSigns VS4
K151761 · DSJ
Phillips Medical Systems
Cardiovascular · 92d
Cleared Sep 29, 2015
U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood...
K151100 · NBW
Taidoc Technology Corporation
Chemistry · 158d
Cleared Sep 24, 2015
iHealth BP3L Wireless Blood Pressure Monitor
K152003 · DXN
Andon Health Co, Ltd.
Cardiovascular · 66d
Cleared Sep 23, 2015
iHealth View BP7S Wireless Blood Pressure Wrist Monitor
K152379 · DXN
Andon Health Co, Ltd.
Cardiovascular · 33d
Cleared Sep 17, 2015
FreeStyle InsuLinx Blood Glucose Monotioring System
K152328 · LFR
Abott Laboratories
Chemistry · 30d
Cleared Sep 11, 2015
Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC...
K151368 · LKN
Terumo Bct
Gastroenterology & Urology · 113d
Cleared Sep 10, 2015
Stat Profile Prime ABG Analyzer System
K151982 · CHL
Nova Biomedical Corporation
Chemistry · 55d
Cleared Sep 09, 2015
PAXgene Blood DNA Tube
K142821 · PJE
Preanalytix GmbH
Toxicology · 344d
Cleared Sep 08, 2015
Fully Automatic Electronic Blood Pressure Monitor
K151460 · DXN
Andon Health Co, Ltd.
Cardiovascular · 99d
Cleared Sep 05, 2015
On Call Express Pro Blood Glucose Monitoring System
K151595 · NBW
ACON Laboratories, Inc.
Chemistry · 85d
Cleared Sep 04, 2015
Art-line Single channel blood pressure system, Art-line Double channel blood...
K151040 · DRS
Biometrix , Ltd.
Cardiovascular · 137d
Cleared Sep 02, 2015
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K151869 · DXN
Microlife Intellectual Property GmbH,...
Cardiovascular · 55d
Cleared Aug 26, 2015
GDH Professional Blood Glucose Monitoring System and GDH Professional LED...
K150274 · NBW
Infopia Co, Ltd.
Chemistry · 203d
Cleared Aug 20, 2015
OC-Light S FIT
K143325 · KHE
Eiken Chemical Co., Ltd.
Hematology · 273d
Cleared Aug 18, 2015
Full Automatic (NIBP)Blood Pressure Monitor
K150311 · DXN
Health & Life Co., Ltd.
Cardiovascular · 190d
Cleared Aug 12, 2015
Alere Signify H. pylori Whole Blood, Serum, Plasma
K151935 · LYR
Alere San Diego, Incorporated
Microbiology · 29d
Cleared Aug 07, 2015
Digital Automatic Wrist Blood Pressure Monitor MD3200
K151587 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 57d
Cleared Aug 07, 2015
Digital Automatic Wrist Blood Pressure Monitor MD3900
K151583 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 57d
Cleared Aug 07, 2015
Assure Prism multi Blood Glucose Monitoring System
K151164 · NBW
I-Sens, Inc.
Chemistry · 98d
Cleared Aug 06, 2015
ABL80 FLEX CO-OX with AQURE connectivity
K151856 · CHL
Sendx Medical, Inc.
Chemistry · 29d