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"
793–816 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Jun 16, 2017
DORA Tubing Sets for Hemodialysis
K161582 · FJK
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 373d
Cleared Jun 14, 2017
hema-screen SPECIFIC Gold
K171484 · KHE
Immunostics Inc.,
Hematology · 23d
Cleared Jun 14, 2017
TONOPORT VI
K170966 · DXN
Par Medizintechnik GmbH & Co. KG
Cardiovascular · 75d
Cleared Jun 07, 2017
Digital Automatic Blood Pressure Monitor MD3600
K163679 · DXN
Grandway Technology (Shenzhen) Limited
Cardiovascular · 162d
Cleared Jun 07, 2017
Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose...
K162564 · NBW
Tianjin Empecs Medical Device Co., Ltd.
Chemistry · 266d
Cleared May 24, 2017
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit,...
K163172 · DRS
Smiths Medical Asd, Inc.
Cardiovascular · 191d
Cleared May 24, 2017
Matrix Data Management System
K162463 · DXN
Global Instrumentation, LLC
Cardiovascular · 264d
Cleared May 19, 2017
Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder
K163073 · JKA
Sol-Millennium Medical, Inc.
Chemistry · 198d
Cleared May 17, 2017
A&D Medical UB-1100BLE UltraConnect Digital Blood Pressure Monitor
K170196 · DXN
A&D Company, Ltd.
Cardiovascular · 114d
Cleared May 14, 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333 · KHE
Guangzhou Wondfo Biotech Co., Ltd.
Hematology · 265d
Cleared CT May 11, 2017
Fully Automatic Electronic Blood Pressure Monitor
K163276 · DXN
Andon Health Co, Ltd.
Cardiovascular · 171d
Cleared May 09, 2017
Digital Blood Pressure Monitor-Automatic Upper Arm Style
K163606 · DXN
Shenzhen Combei Technology Co., Ltd.
Cardiovascular · 139d
Cleared May 03, 2017
A&D Medical UA-1200BLE UltraConnect Digital Blood Pressure Monitor
K163683 · DXN
A&D Company, Ltd.
Cardiovascular · 126d
Cleared May 02, 2017
iGlucose Blood Glucose Monitoring System
K161790 · NBW
Bionime Corporation
Chemistry · 307d
Cleared Apr 25, 2017
Triton Sponge System
K163507 · PBZ
Gauss Surgical, Inc.,
General & Plastic Surgery · 132d
Cleared Apr 21, 2017
CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless...
K163255 · DXN
Caretaker Medical, LLC
Cardiovascular · 151d
Cleared Apr 21, 2017
VivaChek Ino Blood Glucose Monitoring System
K160179 · NBW
Vivachek Laboratories, Inc.
Chemistry · 450d
Cleared Apr 20, 2017
QiF Blood and Fluid Warmer
K163708 · LGZ
Quality IN Flow , Ltd.
General Hospital · 112d
Cleared Apr 20, 2017
HEM-9210T
K163235 · DXN
Omron Healthcare, Inc.
Cardiovascular · 154d
Cleared Apr 18, 2017
Finapres Nova Noninvasive Hemodynamic Monitor
K160967 · DXN
Finapres Medical Systems B.V.
Cardiovascular · 377d
Cleared Apr 14, 2017
Smart Dongle Blood Glucose Monitoring System
K162382 · NBW
Taidoc Technology Corporation
Chemistry · 233d
Cleared Apr 06, 2017
POGO Automatic Blood Glucose Monitoring System
K162203 · NBW
Intuity Medical, Inc.
Chemistry · 244d
Cleared Apr 05, 2017
Arm automatic blood pressure monitor
K161712 · DXN
Shenzhen Pump Medical System Co., Ltd.
Cardiovascular · 288d
Cleared Mar 31, 2017
SureSigns VS3
K163649 · DSJ
Philips Medical Systems
Cardiovascular · 98d