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"
241–264 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Dec 05, 2023
Electronic Blood Pressure Monitor
K232814 · DXN
Zhuhai Yueja Medical Device...
Cardiovascular · 83d
Cleared Dec 05, 2023
Electronic Blood Pressure Monitor, model: HTD6602US
K223170 · DXN
Hetaida Technology Co., Ltd.
Cardiovascular · 420d
Cleared Dec 04, 2023
Monarch Blood Collection Set
K232308 · JKA
The Monarch Company
General Hospital · 124d
Cleared Dec 01, 2023
TRUENESS™ AIR Blood Glucose Monitoring System
K231476 · NBW
Sinocare, Inc.
Chemistry · 193d
Cleared Dec 01, 2023
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™...
K230391 · JKA
Becton, Dickinson and Company
Chemistry · 290d
Cleared Nov 29, 2023
Blood Pressure Cuff...
K232772 · DXQ
Shenzhen Plinma Technology Co. , Ltd.
Cardiovascular · 79d
Cleared Nov 28, 2023
Blood Pressure Monitor
K232713 · DXN
Guangdong Transtek Medical...
Cardiovascular · 84d
Cleared Nov 28, 2023
Digital Blood Pressure Monitor
K231250 · DXN
Guangdong Genial Technology Co., Ltd.
Cardiovascular · 211d
Cleared Nov 27, 2023
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary...
K230493 · GIM
Becton, Dickinson and Company
Hematology · 277d
Cleared Nov 22, 2023
Blood pressure monitor
K232621 · DXN
Guangdong Transtek Medical...
Cardiovascular · 85d
Cleared Nov 22, 2023
Medifun Lancing Device, Model No. LD-E1
K231797 · QRL
Medifun Corporation
General & Plastic Surgery · 155d
Cleared Nov 22, 2023
Digital Blood Pressure Monitor (Arm Type)
K231245 · DXN
Guangdong Genial Technology Co., Ltd.
Cardiovascular · 205d
Cleared Nov 17, 2023
Edwards Algorithm for Measurement of Blood Hemoglobin
K230612 · MUD
Edwards Lifesciences, LLC
Cardiovascular · 256d
Cleared Nov 13, 2023
Accu-Chek Safe-T-Pro Uno Lancing Device
K232509 · FMK
Roche Diabetes Care, Inc.
General & Plastic Surgery · 87d
Cleared Nov 13, 2023
Accu-Chek Safe-T-Pro Plus Lancing Device
K232488 · FMK
Roche Diabetes Care, Inc.
General & Plastic Surgery · 88d
Cleared Nov 08, 2023
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U,...
K231773 · DTZ
Qura S.R.L
Cardiovascular · 145d
Cleared Nov 03, 2023
Endophys Blood Pressure Monitor model BPM-30
K231586 · DSK
Endophys Technologies, LLC
Cardiovascular · 156d
Cleared Oct 31, 2023
OCS Heart Leukocyte Depleting Filter
K231362 · DTM
TransMedics, Inc.
Cardiovascular · 173d
Cleared Oct 27, 2023
Electronic Blood Pressure Monitor
K231310 · DXN
Shenzhen Jumper Medical Equipment...
Cardiovascular · 175d
Cleared Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
K230285 · CHL
Abbott Point of Care, Inc.
Chemistry · 267d
Cleared Oct 27, 2023
Safety butterfly type blood collection needle, Butterfly type blood...
K213146 · JKA
Jiangsu Rongye Technology Co., Ltd.
General Hospital · 760d
Cleared Oct 26, 2023
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)
K233091 · KFM
Qura S.R.L
Cardiovascular · 30d
Cleared Oct 24, 2023
Acumen IQ finger cuff
K230919 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 204d
Cleared Oct 11, 2023
Arm Blood Pressure Monitor
K231050 · DXN
Alicn Medical (Shenzhen), Inc.
Cardiovascular · 181d