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"
1321–1344 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Mar 29, 2012
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700
K110737 · NBW
Bionime Corporation
Chemistry · 379d
Cleared Mar 28, 2012
GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS...
K113547 · CGA
Apex BioTechnology Corp.
Chemistry · 118d
Cleared Mar 28, 2012
EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM
K113243 · LFR
Eps Bio Technology Corp.
Chemistry · 147d
Cleared Mar 28, 2012
CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER
K110894 · LFR
Bayer Healthcare
Chemistry · 364d
Cleared Mar 28, 2012
CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR...
K110587 · LFR
Bayer Healthcare, LLC
Chemistry · 393d
Cleared Mar 22, 2012
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET...
K111702 · LKN
Fenwal, Inc.
Gastroenterology & Urology · 279d
Cleared Mar 19, 2012
ABL90 FLEX
K120197 · CHL
Radiometer Medical Aps
Chemistry · 56d
Cleared Mar 16, 2012
BD BACTEC Plus Aerobic/F Culture Vials (plastic)
K113558 · MDB
Becton, Dickinson and Company
Microbiology · 106d
Cleared Mar 16, 2012
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF)
K113239 · DXN
Health & Life Co., Ltd.
Cardiovascular · 135d
Cleared Mar 13, 2012
DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM
K103329 · NBW
Delbio Incorporation
Chemistry · 487d
Cleared Mar 13, 2012
AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
K103116 · CGA
Bestgen Biotech Corp.
Chemistry · 509d
Cleared Mar 09, 2012
NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS
K112638 · NBW
Nova Biomedical Corporation
Chemistry · 182d
Cleared Mar 06, 2012
CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM
K111268 · LFR
Bayer Healthcare
Chemistry · 307d
Cleared Mar 02, 2012
ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE)
K113264 · DXN
Ld Technology, LLC
Cardiovascular · 119d
Cleared Mar 01, 2012
FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR
K113238 · DXN
Health & Life Co., Ltd.
Cardiovascular · 120d
Cleared Mar 01, 2012
CURAD COMPRESSION HOSIERY
K112769 · DWL
Medline Industries, Inc.
General Hospital · 160d
Cleared Feb 28, 2012
MEDISIGN BLOOD GLUCOSE MONITORING SYSTEM
K111456 · NBW
Tianjin Empecs Medical Device Co., Ltd.
Chemistry · 279d
Cleared Feb 24, 2012
BLOOD PRESSURE MONITOR
K112691 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 162d
Cleared Feb 24, 2012
BLOOD PRESSURE MONITOR
K112690 · DXN
Nihon Seimitsu Sokki Co., Ltd.
Cardiovascular · 162d
Cleared Feb 21, 2012
BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR
K111141 · DXN
Wenzhou Bokang Instruments Co., Ltd.
Cardiovascular · 305d
Cleared Feb 16, 2012
FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS
K111874 · LFR
Abbott Laboratories
Chemistry · 230d
Cleared Feb 14, 2012
VITAL SIGNS MONITOR
K120144 · DXN
Edan Instruments, Inc.
Cardiovascular · 27d
Cleared Feb 14, 2012
SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VS4 VITAL SIGNS MONITOR
K120132 · DXN
Philips Medical Systems
Cardiovascular · 28d
Cleared Feb 10, 2012
KINGYIELD WRIST BLOOD PRESSURE MONITOR
K112042 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 207d