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"
1105–1128 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Dec 19, 2013
SMARTLOG DIABETES MANAGEMENT SOFTWARE
K133346 · NBW
I-Sens, Inc.
Chemistry · 50d
Cleared Dec 19, 2013
ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM
K132086 · NBW
ACON Laboratories, Inc.
Chemistry · 167d
Cleared Dec 16, 2013
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES
K132240 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 151d
Cleared Dec 12, 2013
HEALTHPRO PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM
K132862 · NBW
Infopia Co, Ltd.
Chemistry · 91d
Cleared Dec 06, 2013
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA...
K132429 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 123d
Cleared Dec 05, 2013
GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE...
K132966 · NBW
Infopia Co, Ltd.
Chemistry · 76d
Cleared Nov 26, 2013
PRODIGY CHOICE
K122340 · NBW
Prodigy Diabetes Care, LLC
Chemistry · 481d
Cleared Nov 22, 2013
CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE...
K132288 · NBW
I-Sens, Inc.
Chemistry · 122d
Cleared Nov 22, 2013
REDSENSE ALARM SYSTEM
K130554 · ODX
Redsense Medical AB
Gastroenterology & Urology · 263d
Cleared Nov 22, 2013
GLB BENECHECK PREMIUM GLU MONITORING SYSTEM
K123090 · NBW
General Life Biotechnology Co., Ltd.
Chemistry · 417d
Cleared Nov 20, 2013
AGAMATRIX HEALTH MANAGER
K132821 · NBW
Agamatrix, Inc.
Chemistry · 72d
Cleared Nov 19, 2013
AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
K132712 · KFM
Medtronic, Inc.
Cardiovascular · 82d
Cleared Nov 14, 2013
BOSCH BLOOD PRESSURE METER (BP5000 BT)
K131026 · DXN
Robert Bosch Healthcare Systems, Inc.
Cardiovascular · 216d
Cleared Nov 12, 2013
QUADROX-IR ADULT AND SMALL ADULT
K133265 · KFM
Maquet Cardiopulmonary, AG
Cardiovascular · 20d
Cleared Nov 06, 2013
UNISTRIP 1
K113135 · NBW
Unistrip Technologies, LLC
Chemistry · 744d
Cleared Nov 05, 2013
PREFERRED BLOOD GLUCOSE MONITORING SYSTEM
K122338 · NBW
Prodigy Diabetes Care, LLC
Chemistry · 460d
Cleared Oct 30, 2013
VENOUS HARDSHELL CARDIOTOMY RESERVOIR
K132166 · DTN
Maquet Cardiopulmonary, AG
Cardiovascular · 110d
Cleared Oct 28, 2013
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE
K132972 · DTN
Medtronic, Inc.
Cardiovascular · 35d
Cleared Oct 24, 2013
DA01 BLOOD GLUCOSE MONITORING SYSTEM
K132338 · NBW
Delbio Incorporation
Chemistry · 90d
Cleared Oct 23, 2013
AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K132627 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 62d
Cleared Oct 17, 2013
GLOOKO DEVICE SYSTEM FOR GLOOKO APPLICATION
K132272 · NBW
Glooko, Inc.
Chemistry · 87d
Cleared Oct 17, 2013
FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM
K131013 · NBW
Nova Biomedical Corporation
Chemistry · 189d
Cleared Oct 17, 2013
LEGACY MEDICAL ECO-CHOICE DISPOSABLE BLOOD PRESSURE CUFF
K130942 · DXQ
Legacy Medical, Inc.
Cardiovascular · 196d
Cleared Oct 11, 2013
ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM
K131366 · LFR
Roche Diagnostics Operations, Inc.
Chemistry · 151d