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"
505–528 of 5,555
Search insights Median review: 88d Cleared: 100% Top manufacturer: Taidoc Technology Corporation Lead specialty: Cardiovascular
Cleared Apr 01, 2021
Omron Model BP7900 Blood Pressure Monitor + EKG
K202228 · DXN
Omron Healthcare, Inc.
Cardiovascular · 237d
Cleared Apr 01, 2021
B-Capta
K202154 · DRY
Livanova Deutschland, GmbH
Cardiovascular · 241d
Cleared Mar 26, 2021
TandemHeart Pump and Escort Controller
K202751 · QNR
Cardiacassist, Inc.
Cardiovascular · 186d
Cleared Mar 23, 2021
Aneroid Sphygmomanometer
K203620 · DXQ
Wuxi Exanovo Medical Instrument Co.,...
Cardiovascular · 102d
Cleared Mar 10, 2021
NovaLine Tubing Sets for Hemodialysis
K201866 · FJK
Bain Medical Equipment (Guangzhou)...
Gastroenterology & Urology · 246d
Cleared Mar 10, 2021
FloPump 57mL Centrifugal Pump
K193663 · KFM
International Biophysics Corporation
Cardiovascular · 435d
Cleared Mar 09, 2021
Blood Pressure Monitor
K202891 · DXN
Guangdong Transtek Medical...
Cardiovascular · 162d
Cleared Feb 19, 2021
Safety Blood Collection Sets for Single Use
K202188 · JKA
Anhui Hongyu Wuzhou Medical...
General Hospital · 199d
Cleared Feb 11, 2021
CATSmart, Automated Blood Processing Autotransfusion System
K210089 · CAC
Fresenius Kabi AG
Cardiovascular · 29d
Cleared Feb 10, 2021
Meditech ABPM-06 (BP6)
K201332 · DXN
Meditech , Ltd.
Cardiovascular · 267d
Cleared Jan 27, 2021
Arm Electronic Sphygmomanometer
K193387 · DXN
Shenzhen Changkun Technology Co., Ltd.
Cardiovascular · 418d
Cleared Jan 27, 2021
Wrist Electronic Sphygmomanometer
K193386 · DXN
Shenzhen Changkun Technology Co., Ltd.
Cardiovascular · 418d
Cleared Jan 26, 2021
Blood Pressure Monitor
K202934 · DXN
Bioland Technology, Ltd.
Cardiovascular · 119d
Cleared Jan 22, 2021
EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000...
K203131 · DXN
Edwards Lifesciences, LLC
Cardiovascular · 95d
Cleared Jan 06, 2021
Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood...
K203652 · DXQ
Jkh USA, LLC
Cardiovascular · 23d
Cleared Jan 06, 2021
InBody
K200560 · DXN
Inbody Co., Ltd.
Cardiovascular · 308d
Cleared Jan 05, 2021
Bidop 7
K201114 · DPW
Koven Technology, Inc.
Cardiovascular · 253d
Cleared Dec 30, 2020
Upper Arm Electronic Blood Pressure Monitor
K202372 · DXN
Conmo Electronic Company Limited
Cardiovascular · 133d
Cleared Dec 27, 2020
MBT Sepsityper
K193419 · QNJ
Bruker Daltonik GmbH
Microbiology · 384d
Cleared Dec 23, 2020
SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set
K193670 · KDI
Quanta Dialysis Technologies, Ltd.
Gastroenterology & Urology · 358d
Cleared Dec 17, 2020
Wrist Type Blood Pressure Monitor
K200346 · DXN
Avita Corporation
Cardiovascular · 310d
Cleared Dec 06, 2020
Transtek Wrist Blood Pressure Monitor
K202599 · DXN
Guangdong Transtek Medical...
Cardiovascular · 89d
Cleared Dec 04, 2020
Electronic Blood Pressure Monitor
K200716 · DXN
Shenzhen Pango Electronic Co., Ltd.
Cardiovascular · 261d
Cleared Dec 04, 2020
InBody
K200442 · DXN
Inbody Co., Ltd.
Cardiovascular · 284d