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"
1225–1248 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Jan 25, 2013
RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE...
K123008 · NBW
Bionime Corporation
Chemistry · 120d
Cleared Jan 25, 2013
BACT/ALERT FN PLUS CULTURE BOTTLE
K121455 · MDB
bioMerieux, Inc.
Microbiology · 254d
Cleared Jan 25, 2013
BACT/ALERT PF PLUS CULTURE BOTTLE
K121446 · MDB
bioMerieux, Inc.
Microbiology · 255d
Cleared Jan 22, 2013
BACT/ALERT FA PLUS CULTURE BOTTLE
K121461 · MDB
bioMerieux, Inc.
Microbiology · 250d
Cleared Jan 14, 2013
FORA V10 BLOOD GLUCOSE MONITORING SYSTEM
K121706 · CGA
Foracare, Inc.
Chemistry · 220d
Cleared Jan 11, 2013
WA SERIES: WA100
K123839 · DXN
Ningbo Diaier Electronic Co., Ltd.
Cardiovascular · 29d
Cleared Jan 10, 2013
BLOOD CULTURE HOLDER
K122687 · JKA
Greiner Bio-One North America, Inc.
Chemistry · 128d
Cleared Jan 09, 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL...
K122914 · DTN
Medtronic, Inc.
Cardiovascular · 110d
Cleared Jan 03, 2013
MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGER
K122943 · DPT
Moor Instruments, Ltd.
Cardiovascular · 101d
Cleared Dec 28, 2012
OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTROL KIT OSOM IFOB...
K121397 · KHE
SEKISUI Diagnostics, LLC
Hematology · 233d
Cleared Dec 27, 2012
QUICK SAMPLER HOLDER
K120490 · JKA
Nipro Medical Corporation
Chemistry · 314d
Cleared Dec 21, 2012
TRANSTEK WRIST BLOOD PRESSURE MONITOR
K123669 · DXN
Zhongshan Transtek Electronics Co., Ltd.
Cardiovascular · 22d
Cleared Dec 21, 2012
GLOOKO LOGBOOK CHARTS
K122142 · NBW
Glooko, Inc.
Chemistry · 155d
Cleared Dec 20, 2012
FUTURO (TM) TRAVEL KNEE-HIGHS
K123085 · DWL
3M Company
General Hospital · 80d
Cleared Dec 20, 2012
NOVA ONE BLOOD GLUCOSE MONITOR
K122435 · LFR
Nova Biomedical Corporation
Chemistry · 132d
Cleared Dec 19, 2012
IND ONE STEP OCCULT BLOOD (FOB) TEST
K113506 · KHE
Ind Diagnostics, Inc.
Hematology · 387d
Cleared Dec 18, 2012
ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS
K123561 · DWL
Bsn Medical, Inc.
General Hospital · 29d
Cleared Dec 18, 2012
DR. SCHOLL'S COMPRESSION SOCKS
K123398 · DWL
Renfro Corporation
General Hospital · 43d
Cleared Dec 14, 2012
ON CALL VIVID BLOOD GLUCOSE MONITORING SYSTEM
K123010 · NBW
ACON Laboratories, Inc.
Chemistry · 78d
Cleared Dec 11, 2012
CARDIOSCOPE
K121266 · DXN
Pulsecor Limited
Cardiovascular · 229d
Cleared Dec 11, 2012
DA01 BLOOD GLUCOSE MONITORING SYSTEM
K120866 · NBW
Delbio Incorporation
Chemistry · 264d
Cleared Dec 07, 2012
TL-300 T-LINE NON-INVASIVE BLOOD PRESSURE MONITORING SYSTEM
K123446 · DXN
United States Gtm Medical Devices, Inc.
Cardiovascular · 29d
Cleared Dec 07, 2012
AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
K122760 · DTM
Medtronic, Inc.
Cardiovascular · 88d
Cleared Dec 07, 2012
BLOOD GLUCOSE MONITORING SYSTEM
K120813 · NBW
Andon Medical Co., Ltd.
Chemistry · 263d