Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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5,555 results for "blood"
673–696 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Dec 13, 2018
StatStrip Xpress Glucose Hospital Meter System
K182552 · PZI
Nova Biomedical Corporation
Chemistry · 87d
Cleared Dec 13, 2018
StatStrip Xpress 2 Glucose Hospital Meter System
K182549 · PZI
Nova Biomedical Corporation
Chemistry · 87d
Cleared Dec 13, 2018
Accu-Chek Guide Me Blood Glucose Monitoring System
K181131 · NBW
Roche Diabetes Care
Chemistry · 227d
Cleared CT Dec 04, 2018
AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer...
K180615 · LKN
Fresenius Kabi USA,Llc
Gastroenterology & Urology · 271d
Cleared Dec 03, 2018
Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles,...
K182146 · FMI
Sol-Millennium Medical, Inc.
General Hospital · 117d
Cleared Nov 30, 2018
EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or...
K182245 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 102d
Cleared Nov 30, 2018
Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood...
K182046 · NBW
Tyson Bioresearch, Inc.
Chemistry · 122d
Cleared Nov 30, 2018
POPS! one Blood Glucose Monitoring System
K181588 · NBW
Taidoc Technology Corporation
Chemistry · 168d
Cleared Nov 29, 2018
Tyson Bio HT100-A Blood Glucose Monitoring System
K182047 · NBW
Tyson Bioresearch, Inc.
Chemistry · 121d
Cleared Nov 28, 2018
BGM014 Blood Glucose Monitoring System
K182992 · NBW
Apex BioTechnology Corp.
Chemistry · 30d
Cleared Nov 09, 2018
HEM-6410T-ZM Wrist Blood Pressure Monitor
K182481 · DXN
Omron Healthcare, Inc.
Cardiovascular · 60d
Cleared Nov 08, 2018
Wrist Blood Pressure Monitor Model BP4350
K182166 · DXN
Omron Healthcare, Inc.
Cardiovascular · 90d
Cleared Nov 08, 2018
VAMP Plus Venous/Arterial Blood Management Protection System
K181684 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 135d
Cleared Nov 06, 2018
Finapres Nova Noninvasive Hemodynamic Monitor
K173916 · DXN
Finapres Medical Systems B.V.
Cardiovascular · 319d
Cleared Nov 02, 2018
Wrist Blood Pressure Monitor Model BP6100
K182127 · DXN
Omron Healthcare, Inc.
Cardiovascular · 88d
Cleared Nov 02, 2018
CDI Blood Parameter Monitoring System 550
K182110 · DRY
Terumo Cardiovascular Systems...
Cardiovascular · 88d
Cleared Nov 01, 2018
GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine...
K181273 · NBW
I-Sens, Inc.
Chemistry · 171d
Cleared Nov 01, 2018
Spectra Optia Apheresis System
K181049 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 195d
Cleared Oct 24, 2018
VAMP Optima closed blood sampling system
K180275 · KRA
Edwards Lifesciences, LLC
Cardiovascular · 266d
Cleared Oct 17, 2018
Full Automatic(NIBP) Blood Pressure Monitor
K180240 · DXN
Health & Life Co., Ltd.
Cardiovascular · 261d
Cleared Oct 06, 2018
Bluetooth blood pressure monitor
K182018 · DXN
Shenzhen Kingyield Technology Co., Ltd.
Cardiovascular · 71d
Cleared Oct 03, 2018
On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose...
K181527 · NBW
ACON Laboratories, Inc.
Chemistry · 114d
Cleared Sep 28, 2018
Kawasumi Laboratories Blood Drawing Kit (BDK) System
K172957 · KSB
Kawasumi Laboratories, Inc.
General Hospital · 367d
Cleared Sep 19, 2018
Oh'Care Lite Smart Blood Glucose Monitoring System
K182286 · NBW
Osang Healthcare Co. , Ltd.
Chemistry · 27d