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"
745–768 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Jan 26, 2018
Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A,...
K172896 · DXN
Shenzhen Jiacom Technology CO ., Ltd.
Cardiovascular · 126d
Cleared Jan 17, 2018
epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test
K171247 · CDS
Epocal, Inc.
Chemistry · 264d
Cleared Jan 10, 2018
Digital Blood Pressure Monitor-Wrist Style
K171833 · DXN
Shenzhen Combei Technology Co., Ltd.
Cardiovascular · 205d
Cleared Dec 29, 2017
GEM Premier 5000
K173403 · CHL
Instrumentation Laboratory CO
Chemistry · 59d
Cleared Dec 19, 2017
Reusable Blood Pressure Cuff
K171889 · DXQ
Suzhou Minhua Medical Apparatus...
Cardiovascular · 176d
Cleared Dec 18, 2017
Automated Blood Coagulation Analyzer CS-2500
K172286 · JPA
Siemens Healthcare Diagnostic...
Hematology · 143d
Cleared Dec 15, 2017
V10
K170497 · DXN
Mediana Co., Ltd.
Cardiovascular · 301d
Cleared Dec 15, 2017
FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
K170029 · KFM
International Biophysics Corporation
Cardiovascular · 345d
Cleared Dec 14, 2017
CAREline Airless Hemodialysis Blood Tubing Sets
K172238 · KOC
Fresenius Medical Care Renal...
Gastroenterology & Urology · 141d
Cleared Dec 13, 2017
NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose...
K171480 · NBW
I-Sens, Inc.
Chemistry · 208d
Cleared Dec 11, 2017
Safety Blood Collection Device for Single Use
K170276 · FMI
Gemtier Medical (Shanghai), Inc.
General Hospital · 315d
Cleared Nov 22, 2017
The Wrist-Type Fully Automatic Digital Blood Pressure Monitors
K170666 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 261d
Cleared Nov 21, 2017
Automatic Wrist Bluetooth Blood Pressure Monitor
K170545 · DXN
Truly Instrument , Ltd.
Cardiovascular · 270d
Cleared Nov 20, 2017
Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
K173044 · DXQ
Ningbo Albert Novosino Co., Ltd.
Cardiovascular · 53d
Cleared Nov 09, 2017
HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit,...
K172458 · DRS
Smiths Medical Asd, Inc.
Cardiovascular · 87d
Cleared Nov 07, 2017
StatStrip Xpress Blood Glucose Monitoring System
K170464 · NBW
Nova Biomedical Corporation
Chemistry · 265d
Cleared Nov 06, 2017
gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel...
K172712 · FMK
Gri Medical & Electronic Technology...
General & Plastic Surgery · 59d
Cleared Nov 02, 2017
PixoTest Blood Glucose Monitoring System
K163087 · NBW
Ixensor Company , Ltd.
Chemistry · 364d
Cleared Oct 27, 2017
SANGRAY
K172087 · MOT
Hitachi , Ltd.
Radiology · 108d
Cleared Oct 27, 2017
Automatic Blood Pressure Monitor Model LD-518 & LD-537
K170466 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 254d
Cleared Oct 25, 2017
Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U
K170454 · DXN
Honsun (Nantong) Co., Ltd.
Cardiovascular · 252d
Cleared Oct 19, 2017
CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT...
K170614 · NBW
I-Sens, Inc.
Chemistry · 232d
Cleared Oct 17, 2017
SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare...
K160282 · NBW
Sd Biosensor
Chemistry · 623d
Cleared Oct 13, 2017
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y
K172498 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 56d