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"
529–552 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Oct 16, 2020
Finetest Lite Smart Blood Glucose Monitoring System
K201396 · NBW
Osang Healthcare Co. , Ltd.
Chemistry · 141d
Cleared Oct 09, 2020
V20, V20a, AVSM3 SNF
K200434 · DXN
Mediana Co., Ltd.
Cardiovascular · 228d
Cleared Oct 08, 2020
Steripath Micro Blood Collection System
K200661 · FPA
Magnolia Medical Technologies, Inc.
General Hospital · 210d
Cleared Oct 02, 2020
Quantum Workstation 12 Elite
K202557 · DRY
Spectrum Medical , Ltd.
Cardiovascular · 29d
Cleared Oct 02, 2020
X100 with Full Field Peripheral Blood Smear (PBS) Application
K201301 · JOY
Scopio Labs , Ltd.
Hematology · 140d
Cleared Sep 25, 2020
BD Preset Syringe & BD A-Line Syringe
K202446 · JKA
Becton, Dickinson and Company
Chemistry · 30d
Cleared Sep 21, 2020
Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B
K201467 · DXN
Bioland Technology, Ltd.
Cardiovascular · 111d
Cleared Sep 18, 2020
CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and...
K201207 · KOC
Fresenius Medical Care Renal...
Gastroenterology & Urology · 136d
Cleared Sep 18, 2020
Intellifuse Administration and Intellifuse Blood Administration Sets
K192375 · FPA
Smiths Medical Asd, Inc.
General Hospital · 385d
Cleared Sep 15, 2020
Accelerate Pheno System, Accelerate PhenoTest BC Kit
K192665 · PRH
Accelerate Diagnostics, Inc.
Microbiology · 356d
Cleared Sep 11, 2020
AMICUS Separator System
K200530 · GKT
Fresenius Kabi AG
Gastroenterology & Urology · 193d
Cleared Sep 11, 2020
GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose...
K193340 · NBW
Microtech Medical, Inc.
Chemistry · 284d
Cleared Sep 09, 2020
KetoSens BT Blood B-Ketone Monitoring System
K201551 · JIN
I-Sens, Inc.
Chemistry · 92d
Cleared Sep 09, 2020
Blood Collection Needle with/without Holder, Safety Blood Collection Needle...
K200027 · JKA
Jiangsu Caina Medical Co.,Ltd
General Hospital · 247d
Cleared Sep 02, 2020
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal...
K202169 · KFM
Qura S.R.L
Cardiovascular · 30d
Cleared Aug 21, 2020
Quantra QPlus System
K201513 · QFR
Hemosonics, LLC
Hematology · 74d
Cleared Aug 20, 2020
Electronic Blood Pressure Monitor
K200939 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 134d
Cleared Aug 17, 2020
RadGil2
K201177 · MOT
R3 X-Ray L.L.C
Radiology · 108d
Not Cleared Aug 07, 2020
Cell-Free DNA BCT
DEN200001 · QMA
Streck, Inc.
Chemistry · 210d
Cleared Aug 03, 2020
Arm-Type Fully Automatic Digital Blood Pressure Monitor
K200649 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 144d
Cleared Jul 28, 2020
Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein...
K192681 · FPA
Jiangsu Kangbao Medical Equipment...
General Hospital · 306d
Cleared Jul 23, 2020
Microlife Upper Arm Automatic Digital Blood Pressure Monitor
K200738 · DXN
Microlife Intellectual Property GmbH
Cardiovascular · 122d
Cleared Jul 16, 2020
Arm Blood Pressure Monitor
K193456 · DXN
Ningbo Ranor Medical Science &...
Cardiovascular · 216d
Cleared Jul 12, 2020
AGE Automatic Wrist Blood Pressure Monitor
K193628 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 199d