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"
1081–1104 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Apr 10, 2014
BIO-PROBE TRANSDUCER (ADULT)
K133903 · DPT
Medtronic, Inc.
Cardiovascular · 111d
Cleared Apr 10, 2014
ELEMENT TM LITE BLOOD GLUCOSE MONITORING SYSTEM
K133045 · NBW
Infopia Co, Ltd.
Chemistry · 195d
Cleared Mar 25, 2014
NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
K131703 · CHL
Nova Biomedical Corporation
Chemistry · 287d
Cleared Mar 24, 2014
WITHINGS BLOOD PRESURE MONITOR
K133125 · DXN
Withings
Cardiovascular · 175d
Cleared Mar 11, 2014
BPROSOFT CASP PC SOFTWARE
K131916 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 258d
Cleared Mar 06, 2014
AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM
K131750 · CGA
Apex BioTechnology Corp.
Chemistry · 265d
Cleared Mar 05, 2014
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES
K133619 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 100d
Cleared Mar 05, 2014
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES
K133618 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 100d
Cleared Mar 04, 2014
HEM-7320
K133383 · DXN
Omron Healthcare, Inc.
Cardiovascular · 120d
Cleared Mar 04, 2014
ANDON BLOOD PRESSURE CUFF
K133117 · DXQ
Andon Health Co, Ltd.
Cardiovascular · 155d
Cleared Mar 04, 2014
HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT...
K131788 · DXN
Healthstats International Pte. , Ltd.
Cardiovascular · 259d
Cleared Feb 28, 2014
CERA-CHEK 1070 BLOOD GLUCOSE MONITORING SYSTEM
K131727 · LFR
Ceragem Medisys, Inc.
Chemistry · 261d
Cleared Feb 27, 2014
EMV3.1 PRO BLOOD GLUCOSE SYSTEM AND EMV3.1 SELF MONITORING BLOOD GLUCOSE SYSTEM
K133647 · NBW
Eps Bio Technology Corp.
Chemistry · 92d
Cleared Feb 21, 2014
EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE...
K133509 · NBW
Biotest Medical Corp.
Chemistry · 99d
Cleared Jan 29, 2014
MOORLDLS-BI LASER DOPPLER BURNS IMAGER
K132163 · DPT
Moor Instruments, Ltd.
Cardiovascular · 201d
Cleared Jan 17, 2014
OREGON SCINTIFIC
K131245 · DXN
Idt Technology Limited
Cardiovascular · 261d
Cleared Jan 17, 2014
GLUCOMENTOR BLOOD GLUCOSE MONITORING SYSTEM, GLUCOMENTOR MULTI BLOOD GLUCOSE...
K123517 · NBW
Sd Biosensor
Chemistry · 429d
Cleared Jan 16, 2014
HEM-7311
K133379 · DXN
Omron Healthcare, Inc.
Cardiovascular · 73d
Cleared Jan 13, 2014
GEM PREMIER 4000
K133407 · CHL
Instrumentation Laboratory CO
Chemistry · 68d
Cleared Jan 08, 2014
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
K132843 · PEN
Nanosphere, Inc.
Microbiology · 120d
Cleared Jan 06, 2014
ACON ON CALL DIABETES MANAGEMENT SOFTWARE
K131469 · NBW
ACON Laboratories, Inc.
Chemistry · 230d
Cleared Dec 24, 2013
FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM
K132511 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 134d
Cleared Dec 24, 2013
ARM AUTOMATIC BLOOD PRESSURE MONITOR
K130325 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 319d
Cleared Dec 20, 2013
ON CALL SHARP BLOOD GLUCOSE MONITORING SYSTEM
K130284 · NBW
ACON Laboratories, Inc.
Chemistry · 318d