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"
1369–1392 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Dec 19, 2011
ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH...
K112587 · DWB
Terumo Cardiovascular Systems Corp.
Cardiovascular · 104d
Cleared Dec 16, 2011
VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
K112424 · NQX
Nanosphere, Inc.
Microbiology · 115d
Cleared Dec 16, 2011
HYPERTENSION MANAGEMENT SOFTWARE CLAIENT SERVER (HMS-CS)
K110603 · DXN
I.E.M. GmbH
Cardiovascular · 288d
Cleared Dec 15, 2011
FORA PREMIUM V10 BLOOD GLUCOSE MONITORING SYSTEM
K112275 · NBW
Taidoc Technology Corporation
Chemistry · 129d
Cleared Dec 14, 2011
COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT...
K112203 · DRS
Mirador Biomedical, Inc.
Cardiovascular · 135d
Cleared Dec 09, 2011
SARN CENTRIFUGAL PUMP
K112229 · KFM
Terumo Cardiovascular Systems
Cardiovascular · 128d
Cleared Dec 09, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-7902BTJ, FULLY...
K111830 · DXN
Andon Health Co, Ltd.
Cardiovascular · 164d
Cleared Dec 09, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K111826 · DXN
Andon Health Co, Ltd.
Cardiovascular · 164d
Cleared Dec 07, 2011
IBGSTAR BLOOD GLUCOSE MONITORING SYSTEM, IBGSTAR DIABETES MANAGER...
K103544 · NBW
Agamatrix, Inc.
Chemistry · 370d
Cleared Dec 05, 2011
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K112845 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 67d
Cleared Nov 22, 2011
TD-4257 BLOOD GLUCOSE MONITORING SYSTEMS,TD 4257 MULTI BLOOD GLUCOSE...
K112963 · NBW
Taidoc Technology Corporation
Chemistry · 48d
Cleared Nov 22, 2011
BESTSHAPE BLOOD PRESSURE MONITORING SYSTEM
K112647 · DXN
Wistron Corporation
Cardiovascular · 71d
Cleared Nov 22, 2011
UNIMED BLOOD PRESSURE CUFF
K112544 · DXQ
Unimed Medical Supplies, Inc.
Cardiovascular · 82d
Cleared Nov 22, 2011
ACCUMED UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR
K112273 · DXN
Accumed Healthcare (Shanghai), Inc.
Cardiovascular · 106d
Cleared Nov 22, 2011
ACCUMED WRIST AUTOMATIC BLOOD PRESSURE MONITOR
K112270 · DXN
Accumed Healthcare (Shanghai), Inc.
Cardiovascular · 106d
Cleared Nov 16, 2011
THE BELMONT BUDDY LITE FLUID WARMER
K112639 · BSB
Belmont Instrument Corp.
Hematology · 65d
Cleared Nov 16, 2011
HEALTHTRACKER
K110770 · DXN
Wistron Corporation
Cardiovascular · 243d
Cleared Nov 10, 2011
IGLUCOSE SYSTEM
K111932 · NBW
Positiveid Corporation
Chemistry · 125d
Cleared Nov 10, 2011
MULTIFUNCTION KEITO
K103058 · DXN
Aguiflai Iberica S.L.
Cardiovascular · 392d
Cleared Nov 09, 2011
SWEETSPOT DIABETES DATA MANAGEMENT SERVICE
K111509 · NBW
Sweetspot Diabetes Care, Inc.
Chemistry · 161d
Cleared Nov 04, 2011
ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K103021 · NBW
Infopia Co, Ltd.
Chemistry · 388d
Cleared Oct 28, 2011
ACURA PLUS BLOOD GLUCOSE MONITORING SYSTEM
K103278 · CGA
I-Sens, Inc.
Chemistry · 357d
Cleared Oct 20, 2011
VANISHPOINT BLOOD COLLECTION SET
K112512 · FPA
Retractable Technologies, Inc.
General Hospital · 51d
Cleared Oct 20, 2011
OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100...
K112269 · DXN
OSTAR MEDITECH CORP.
Cardiovascular · 73d