FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters:
5,538 results for "blood"
1705–1728 of 5,538
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Mar 27, 2009
TRUEBALANCE BLOOD GLUCOSE SYSTEM
K090495 · NBW
Home Diagnostics, Inc.
Chemistry · 30d
Cleared Mar 26, 2009
FORA V12 NO-CODING BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4247
K090536 · NBW
Taidoc Technology Corporation
Chemistry · 27d
Cleared Mar 26, 2009
THE BELMONT BUDDY LITE FLUID WARMER
K090508 · BSB
Belmont Instrument Corp.
Hematology · 28d
Cleared Mar 24, 2009
BETACHEK GLUCOSE TEST
K062187 · NBW
National Diagnostic Products
Chemistry · 966d
Cleared Mar 23, 2009
DEVON ACCUBP CUFF
K090664 · DXQ
Devon Medical, Inc.
Cardiovascular · 10d
Cleared Mar 13, 2009
SYMCARE DIABETES MANAGEMENT PROGRAM
K083263 · NBW
Symcare Personalized Health...
Chemistry · 128d
Cleared Mar 12, 2009
HEMOBAND, MODELS HB-NS AND HB-NSXL
K081740 · KOC
Innovations For Access, Inc.
Gastroenterology & Urology · 266d
Cleared Mar 11, 2009
U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM
K083570 · CGA
Taidoc Technology Corporation
Chemistry · 98d
Cleared Mar 10, 2009
NOVA SAFE SCALP VEIN BLOOD COLLECTION SET
K090502 · FOZ
U.S. Safety Syringes Co., Inc.
General Hospital · 13d
Cleared Feb 27, 2009
SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS:...
K083395 · DXN
Andon Health Co, Ltd.
Cardiovascular · 102d
Cleared Feb 27, 2009
GLUCODR PLUS SYSTEM, MODEL AGM-3000
K082328 · NBW
All Medicus Co., Ltd.
Chemistry · 197d
Cleared Feb 20, 2009
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
K083225 · LZG
Abbott Diabetes Care, Inc.
General Hospital · 109d
Cleared Feb 20, 2009
G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A
K082201 · NBW
U. S. Diagnostics, Inc.
Chemistry · 199d
Cleared Feb 20, 2009
DUO-CARE BLOOD GLUCOSE AND BLOOD PRESSURE MONITOR SYSTEM
K080853 · NBW
Genexel-Sein, Inc.
Chemistry · 331d
Cleared Feb 17, 2009
RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400
K082921 · MOT
Rad Source Technologies, Inc.
Radiology · 139d
Cleared Feb 13, 2009
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
K082321 · KFM
Terumo Cardiovascular Systems Corp.
Cardiovascular · 184d
Cleared Feb 13, 2009
DUO-MAX BLOOD PRESSURE & GLUCOSE MONITOR HMF-100
K080636 · CGA
Hubdic Co., Ltd.
Chemistry · 344d
Cleared Feb 10, 2009
BLOOD TUBING SETS (STERILE FLUID PATH)
K090255 · FJK
Nxstage Medical, Inc.
Gastroenterology & Urology · 8d
Cleared Feb 10, 2009
CARESENS N BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N METER, MODEL GM5051A...
K083468 · NBW
I-Sens, Inc.
Chemistry · 78d
Cleared Feb 04, 2009
MODIFICATION TO PAXGENE BLOOD RNA SYSTEM
K082150 · NTW
Preanalytix GmbH
Pathology · 189d
Cleared Feb 04, 2009
GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING
K082082 · DTN
Gish Biomedical, Inc.
Cardiovascular · 196d
Cleared Feb 04, 2009
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
K081947 · DTN
Gish Biomedical, Inc.
Cardiovascular · 211d
Cleared Feb 03, 2009
JAZZ WIRELESS BLOOD GLUCOSE MONITORING SYSTEM, MODEL 8000-03381
K083265 · NBW
Agamatrix, Inc.
Chemistry · 90d
Cleared Feb 02, 2009
BLOOD PRESSURE MONITOR, ZSBP-003/004/005/006/007/008 AND...
K090027 · DXN
Zen Strong Medical Technology Co., Ltd.
Cardiovascular · 28d