FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,110 results
169–192 of 18,110
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 Feb 13, 2026
PreemptiveAI Clinical SDK
K250233 · DXH
Measure Labs, Inc. (Dba Preemptiveai,...
Cardiovascular · 382d