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

Filters: Cardiovascular ×
18,182 results
241–264 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Mar 12, 2026
InVera Infusion Device
K250794 · KRA
Invera Medical
Cardiovascular · 363d
Cleared Mar 12, 2026
Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3)
K240934 · DTZ
Spectrum Medical S.R.L.
Cardiovascular · 706d
Cleared Mar 11, 2026
Venous Return Cannulae
K250937 · DWF
LivaNova USA, Inc.
Cardiovascular · 348d
Cleared Mar 06, 2026
EmeryGlide™ (EG18008901)
K253262 · DQX
Nano4imaging GmbH
Cardiovascular · 158d
Cleared Mar 05, 2026
YUWELL® Electronic Blood Pressure Monitor (YE630CR)
K252779 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 184d
Cleared Feb 27, 2026
HOTWIRE RF GUIDEWIRE (901XXX)
K260292 · DXF
Atraverse Medical
Cardiovascular · 29d
Cleared Feb 24, 2026
NanoPress 760A-BT (760A-BT)
K254267 · JOW
Mego Afek , Ltd.
Cardiovascular · 56d
Cleared Feb 24, 2026
IntraSight Plus
K253714 · IYO
Philips Image Guided Therapy Corporation
Cardiovascular · 92d
Cleared Feb 24, 2026
HemoSphere Nano Monitor (HSNANO1)
K253186 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 151d
Cleared Feb 23, 2026
Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set...
K260043 · DWF
Smart Reactors
Cardiovascular · 47d
Cleared Feb 23, 2026
YUWELL® Electronic Blood Pressure Monitor (YE650AR)
K253228 · DXN
Jiangsu Yuyue Medical Equipment&...
Cardiovascular · 147d
Cleared Feb 20, 2026
CARTO™ 3 EP Navigation System V8.4
K252972 · DQK
Biosense Webster, Inc.
Cardiovascular · 156d
Cleared Feb 19, 2026
AuST CSP Introducer
K260163 · DYB
CenterPoint Systems, LLC
Cardiovascular · 30d
Cleared Feb 19, 2026
Retrograde Coronary Sinus Perfusion Cannulae
K253203 · DWF
Medtronic, Inc.
Cardiovascular · 146d
Cleared Feb 17, 2026
Versus™ Catheter (VS110-9NB)
K260149 · QEY
Liquet Medical, Inc.
Cardiovascular · 28d
Cleared Feb 17, 2026
IOPS Visionary System (MC-3)
K254089 · DQK
Centerline Biomedical, Inc.
Cardiovascular · 60d
Cleared Feb 13, 2026
Wrist Blood Pressure Monitor (BPM-W1VL)
K253133 · DXN
Shenzhen Imdk Medical Technology Co.,...
Cardiovascular · 141d
Cleared Feb 13, 2026
Argos Infinity (Rev. 1.0)
K253092 · DXG
Retia Medical Systems, Inc.
Cardiovascular · 143d
Cleared Feb 13, 2026
NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712,...
K253089 · DXQ
Shenzhen Best Electronics Co., Ltd.
Cardiovascular · 143d
Cleared Feb 13, 2026
Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L,...
K252685 · DXN
Joytech Healthcare Co. , Ltd.
Cardiovascular · 171d
Cleared Feb 13, 2026
Armada™ 14 NC PTA Catheter
K252512 · LIT
Abbott Medical
Cardiovascular · 186d
Cleared Feb 13, 2026
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01)
K251928 · GEH
Medinice S.A.
Cardiovascular · 235d
Cleared Feb 13, 2026
Wearable Ambulatory Blood Pressure Monitor (WBP-02A)
K251581 · DXN
Shenzhen Hingmed Medical Instrument...
Cardiovascular · 266d
Cleared CT Feb 13, 2026
PreemptiveAI Clinical SDK
K250233 · DXH
Measure Labs, Inc. (Dba Preemptiveai,...
Cardiovascular · 382d