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"
1009–1032 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Mar 12, 2015
Triton Canister System
K142801 · PBZ
Gauss Surgical, Inc.,
General & Plastic Surgery · 164d
Cleared Mar 04, 2015
Hospira Blood Set
K143087 · FPA
Hospira, Inc.
General Hospital · 128d
Cleared Mar 03, 2015
ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM
K141867 · NBW
Roche Diagnostics
Chemistry · 236d
Cleared Jan 30, 2015
FilmArray Blood Culture Identification (BCID) Panel for use with the...
K143171 · PEN
Biofire Diagnostics, LLC
Microbiology · 87d
Cleared Jan 22, 2015
Deltex Medical KDP72 Doppler Probe
K142932 · DPT
Deltex Medical Limited
Cardiovascular · 105d
Cleared Jan 08, 2015
TIVA
K142946 · JKA
Velano Vascular, Inc.
Chemistry · 90d
Cleared Jan 07, 2015
ENDOPHYS BLOOD PRESSURE MONITOR
K141615 · DSK
Endophys, Inc.
Cardiovascular · 205d
Cleared Dec 19, 2014
Full Automatic (NIBP) Blood Pressure Monitor
K142968 · DXN
Health & Life Co., Ltd.
Cardiovascular · 66d
Cleared Dec 10, 2014
BD BACTEC PLUS ANAEROBIC/F (PLASTIC)
K141810 · MDB
Becton, Dickinson and Company
Microbiology · 156d
Cleared Dec 02, 2014
HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE
K141862 · NBW
H2, Inc.
Chemistry · 145d
Cleared Dec 01, 2014
BP652N (HEM-6300-Z)
K142917 · DXN
Omron Healthcare, Inc.
Cardiovascular · 55d
Cleared Nov 25, 2014
AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
K133989 · DXN
Mortara Instrument, Inc.
Cardiovascular · 334d
Cleared Nov 19, 2014
ARM-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
K141755 · DXN
Sejoy Electronics & Instruments Co.,...
Cardiovascular · 142d
Cleared Nov 19, 2014
PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device
K133303 · JKA
Bio-Analysis, Inc.
Chemistry · 390d
Cleared Oct 31, 2014
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR SWBPM22 SERIES
K142088 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 91d
Cleared Oct 23, 2014
TRI-OPTIC MEASUREMENT CELL
K133157 · DRY
Medtronic, Inc.
Cardiovascular · 371d
Cleared Oct 17, 2014
Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
K142220 · CHL
Nova Biomedical Corporation
Chemistry · 66d
Cleared Oct 09, 2014
BLOOD PRESSURE MONITOR
K141416 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 133d
Cleared Oct 08, 2014
A&D MEDICAL UA-767F AND UA-767FAC DIGITAL BLOOD PRESSURE MONITOR
K141201 · DXN
A & D Co., Ltd.
Cardiovascular · 152d
Cleared Oct 07, 2014
A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR
K141160 · DXN
A & D Co., Ltd.
Cardiovascular · 155d
Cleared Sep 30, 2014
FREESTYLE PRECISION NEO BLOOD GLUCOSE: MONITORING SYSTEM, TEST STRIPS (50CT),...
K140371 · NBW
Abbott Diabetes Care, Inc.
Chemistry · 228d
Cleared Sep 26, 2014
SPACELBS MODEL ON TRAK (90227) AMBULATORY BLOODY PRESSURE (ABP) NON-INVASIVE
K141113 · DXN
Spacelabs Healthcare, Ltd.
Cardiovascular · 149d
Cleared Sep 24, 2014
GLUCOVITAAL H1A BLOOD GLUCOSE MONITORING SYSTEM
K141829 · NBW
Ceragem Medisys, Inc.
Chemistry · 79d
Cleared Sep 24, 2014
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
K132121 · PZI
Nova Biomedical Corporation
Chemistry · 441d