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
145–168 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Apr 07, 2026
Firefighter™ Pro PTCA Balloon Catheter
K252116 · LOX
Shanghai MicroPort Medical (Group)...
Cardiovascular · 274d
Cleared Apr 06, 2026
VANES Delivery System (VDS)
K260459 · DYB
Zoll Respicardia, Inc.
Cardiovascular · 54d
Cleared Apr 03, 2026
Etiometry Platform
K254066 · PPW
Etiometry, Inc.
Cardiovascular · 106d
Cleared Apr 03, 2026
Life Saving Tourniquet
K254060 · DXC
TW Medical
Cardiovascular · 107d
Cleared Apr 02, 2026
FLASH Flex™ Aorto-Ostial Angioplasty System
K254022 · LOX
Verge Medical, Inc.
Cardiovascular · 107d
Cleared Apr 01, 2026
Arm Blood Pressure Monitor Models: ARM-30C+
K260276 · DXN
Shenzhen AOJ Medical Technology Co.,...
Cardiovascular · 62d
Cleared Apr 01, 2026
Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL,...
K254225 · DXN
Shenzhen HanHan Technology Co., Ltd.
Cardiovascular · 93d
Cleared Apr 01, 2026
Synchrony
K253473 · DQK
Stereotaxis, Inc.
Cardiovascular · 173d
Cleared Mar 28, 2026
ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020)
K252360 · SAT
Anumana, Inc.
Cardiovascular · 242d
Cleared Mar 27, 2026
Ryurei
K252295 · LOX
Terumo Corporation
Cardiovascular · 247d
Cleared Mar 26, 2026
Multiflex Steerable Sheath 17.5F
K260626 · DYB
Vizaramed, Inc.
Cardiovascular · 28d
Cleared Mar 26, 2026
Automatic Electronic Blood Pressure Monitor (U90B series models including (...
K260273 · DXN
Shenzhen Urion Technology Co., Ltd.
Cardiovascular · 56d
Cleared Mar 25, 2026
Arterial Pressure Monitoring Set/Tray
K254278 · DQO
Spectrum Vascular
Cardiovascular · 85d
Cleared Mar 20, 2026
FMD Peripheral Guide Wire F-14 Flex 6
K260544 · DQX
FMD Co., Ltd.
Cardiovascular · 30d
Cleared Mar 20, 2026
Valvuloplasty Balloon Catheter (ValvuloPro)
K260437 · OZT
Dongguan TT Medical, Inc.
Cardiovascular · 37d
Cleared Mar 20, 2026
FLOWRUNNER Aspiration System
K254208 · QEZ
Expanse Medical, Inc.
Cardiovascular · 81d
Cleared Mar 19, 2026
Enroute 0.014'' Transcarotid Guidewire
K253746 · DQX
Lake Region Medical
Cardiovascular · 114d
Cleared Mar 18, 2026
LimFlow Vector
K260188 · MGZ
LimFlow, Inc.
Cardiovascular · 55d
Cleared Mar 16, 2026
Lifemotion Disposable Membrane Oxygenator
K253838 · DTZ
Lifemotion Medical Technology Co., Ltd.
Cardiovascular · 105d
Cleared Mar 13, 2026
Amplatzer™ Trevisio™ Intravascular Delivery System
K260499 · DQY
Abbott Medical
Cardiovascular · 28d
Cleared Mar 13, 2026
SafeSept RF Transseptal Guidewire (SSRF132
K253799 · DXF
Pressure Products Medical Device...
Cardiovascular · 105d
Cleared Mar 13, 2026
OptiMap Catheter - 50mm (OPTI-CATH2-50)
K253205 · MTD
Cortex, Inc.
Cardiovascular · 168d
Cleared Mar 12, 2026
Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W
K252541 · DTR
Spectrum Medical S.R.L.
Cardiovascular · 212d
Cleared Mar 12, 2026
Tyto Stethoscope (G3)
K252089 · DQD
Tyto Care , Ltd.
Cardiovascular · 253d