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
217–240 of 18,182
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