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

5,555 results for "blood"
193–216 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Jun 07, 2024
Blood Pressure Monitor (BBZ32-AA01)
K240832 · DXN
Guangdong Transtek Medical...
Cardiovascular · 73d
Cleared Jun 06, 2024
WaveSense Jazz Blood Glucose Monitoring System
K241304 · NBW
Agamatrix
Chemistry · 28d
Cleared Jun 04, 2024
LIAISON PLEX Yeast Blood Culture Assay
K240627 · PEO
Luminex Corporation
Microbiology · 90d
Cleared May 31, 2024
Blood Pressure Monitor (TMB-2296-BT)
K240254 · DXN
Guangdong Transtek Medical...
Cardiovascular · 121d
Cleared May 28, 2024
Laser Speckle Imaging System (RFLSI CZW)
K233076 · DPT
Rwd Life Science Co., Ltd.
General & Plastic Surgery · 245d
Cleared May 21, 2024
Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.)
K240806 · FMK
Tianjin Huahong Technology Co., Ltd.
General & Plastic Surgery · 57d
Cleared May 15, 2024
MVR™ Venous Reservoir Bag 800 mL
K241053 · DTN
Medtronic Cardiac Surgery
Cardiovascular · 28d
Cleared Apr 29, 2024
Blood Pressure Monitor (TMB-2287-B)
K240102 · DXN
Guangdong Transtek Medical...
Cardiovascular · 104d
Cleared Apr 26, 2024
UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA...
K232317 · JIO
Urit Medical Electronic Co., Ltd.
Chemistry · 267d
Cleared Apr 26, 2024
ASTar BC G- Kit and ASTar Instrument
K221688 · SAN
Q-Linea AB
Microbiology · 686d
Cleared Apr 26, 2024
cobas pulse blood glucose monitoring system
K220272 · PZI
Roche Diagnostics
Chemistry · 816d
Cleared Apr 25, 2024
CDI OneView Monitoring System
K234065 · DRY
Terumo Cardiovascular Systems...
Cardiovascular · 125d
Cleared Apr 22, 2024
Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA)
K234041 · DXN
Andon Health Co, Ltd.
Cardiovascular · 123d
Cleared Apr 02, 2024
LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System
K211815 · SAN
Affinity Biosensors
Microbiology · 1026d
Cleared CT Mar 27, 2024
QStat Cartridge
K240045 · QFR
Hemosonics, LLC
Hematology · 82d
Cleared Mar 26, 2024
Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP)
K231984 · DXN
Shenzhen Hingmed Medical Instrument...
Cardiovascular · 265d
Cleared Mar 21, 2024
RedDrop ONE (One)
K234081 · FMK
Reddrop DX
General & Plastic Surgery · 90d
Cleared Mar 20, 2024
Aneroid Sphygmomanometer with Stethoscope
K240165 · DXQ
Wenzhou Longwan Medical Device Factory
Cardiovascular · 58d
Cleared Mar 19, 2024
Blood Pressure Monitor
K233146 · DXN
Shenzhen Jamr Technology Co., Ltd.
Cardiovascular · 174d
Cleared Mar 15, 2024
Wrist Blood Pressure Monitor (222)
K233799 · DXN
Shenzhen Yuezhongxing Technology Co.,...
Cardiovascular · 107d
Cleared Mar 07, 2024
Safety Sliding Blood Collection Set
K232781 · JKA
Jiangsu Caina Medical Co.,Ltd
General Hospital · 178d
Cleared Feb 23, 2024
StatStrip Glucose Hospital Meter System
K232075 · PZI
Nova Biomedical Corporation
Chemistry · 226d
Cleared CT Feb 23, 2024
CONTOUR® PLUS BLUE Blood Glucose Monitoring System
K231679 · NBW
Ascensia Diabetes Care
Chemistry · 259d
Cleared Feb 22, 2024
NanoDrop Lancet
K223826 · FMK
Drawbridge Health, Inc.
General & Plastic Surgery · 428d