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"
505–528 of 5,530
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
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
Cleared Jul 12, 2020
Automatic Upper Arm Blood Pressure Monitor
K193627 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 199d