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"
1201–1224 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Apr 05, 2013
DIAVUE PRUDENTIAL BLOOD GLUCOSE MONITORING SYSTEM
K122307 · NBW
Biocare Corporation
Chemistry · 247d
Cleared Apr 04, 2013
NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR
K122688 · LFR
Nova Biomedical Corporation
Chemistry · 212d
Cleared Apr 02, 2013
BOSSONG HOSIERY MEDICAL COMPRESSION STOCKINGS 8-15 MMHG, BOSSONG HOSIERY...
K123820 · DWL
Bossong Hosiery Mills, Inc.
General Hospital · 111d
Cleared Mar 26, 2013
HIGH METABOLITE QUALICHECK
K130415 · JJS
Radiometer Medical Aps
Chemistry · 35d
Cleared Mar 21, 2013
BP652N (HEM-6300-Z)
K123498 · DXN
Omron Healthcare, Inc.
Cardiovascular · 128d
Cleared Mar 21, 2013
APPS-HEALTH01
K122098 · DXN
Andon Health Co, Ltd.
Cardiovascular · 248d
Cleared Mar 20, 2013
E-Z CHEK BLOOD LEAK TEST STRIPS
K123805 · FJD
Reprocessing Products Corp
Gastroenterology & Urology · 99d
Cleared Mar 19, 2013
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
K123351 · DTM
Medtronic Perfusion Systems
Cardiovascular · 139d
Cleared Mar 15, 2013
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK...
K130236 · JJS
Radiometer Medical Aps
Chemistry · 44d
Cleared Mar 15, 2013
SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM
K130138 · NBW
Roche Diagnostics Corp.
Chemistry · 56d
Cleared Mar 11, 2013
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM03 SERIES MODEL MD03X0
K123073 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 161d
Cleared Mar 08, 2013
BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)
K113636 · CGA
Philosys Co., Ltd.
Chemistry · 455d
Cleared Mar 07, 2013
GENESIS HEALTH RECORD SYSTEM, (GHRS)
K123136 · NBW
Genesis Health Technologies
Chemistry · 153d
Cleared Mar 01, 2013
TRANSTEK BLOOD PRESSURE MONITOR
K123780 · DXN
Zhongshan Transtek Electronics Co., Ltd.
Cardiovascular · 81d
Cleared Feb 14, 2013
GOODLIFE CS-200 (SINGLE PATIENT USE), CS-200 PROFESSIONAL (MULTIPLE PATIENT...
K121433 · LFR
Hmd Biomedical, Inc.
Chemistry · 276d
Cleared Feb 14, 2013
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES
K120675 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 346d
Cleared Feb 14, 2013
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES
K120673 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 346d
Cleared Feb 12, 2013
ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM
K113614 · NBW
Roche Diagnostics
Chemistry · 434d
Cleared Feb 11, 2013
BABYLANCE HEEL INCISION DEVICE
K130132 · FMK
Medipurpose Pte. , Ltd.
General & Plastic Surgery · 24d
Cleared Feb 11, 2013
LABONACHECK GLUPPY BLOOD GLUCOSE MONITORING SYSTEM
K102751 · NBW
Ceragem Medisys, Inc.
Chemistry · 872d
Cleared Feb 08, 2013
COMPACT DIGITAL BLOOD PRESSURE MONITOR
K122810 · DXN
Thermor , Ltd.
Cardiovascular · 148d
Cleared Feb 07, 2013
AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY...
K123216 · DPT
Aimago SA
Cardiovascular · 115d
Cleared Feb 07, 2013
ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
K120708 · NBW
Cilag GmbH International
Chemistry · 336d
Cleared Feb 07, 2013
ONETOUCH REVEAL DIABETES MANAGEMENT APPLICATION
K120558 · NBW
Lifescan, Inc.
Chemistry · 349d