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
409–432 of 18,182
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared CT Sep 04, 2025
LIBERTY Endovascular Robotic System (LIBERTYOS)
K243789 · DXX
Microbot Medical , Ltd.
Cardiovascular · 269d
Cleared Sep 03, 2025
AViTA Arm Type Blood Pressure Monitor Cuff
K250765 · DXQ
Avita Corporation
Cardiovascular · 174d
Cleared Sep 03, 2025
Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X,...
K250231 · DXN
Dongguan E-Test Technology Co., Ltd.
Cardiovascular · 219d
Cleared Sep 02, 2025
IntelliVue Patient Monitor 6100 (6100)
K250453 · MHX
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 196d
Cleared Aug 29, 2025
Edwards eSheath Optima introducer set
K252364 · DYB
Edwards Lifesciences
Cardiovascular · 31d
Cleared Aug 29, 2025
Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5)
K251181 · DQX
Merit Medical Ireland, Ltd.
Cardiovascular · 135d
Cleared CT Aug 28, 2025
Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System
K252057 · QEW
Imperative Care, Inc.
Cardiovascular · 58d
Cleared Aug 27, 2025
HOTWIRE RF GUIDEWIRE (901XXX)
K252419 · DXF
Atraverse Medical, Inc.
Cardiovascular · 26d
Cleared Aug 27, 2025
Vital Signs
K243687 · QME
Oxehealth Limited
Cardiovascular · 271d
Cleared Aug 27, 2025
QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)
K241766 · MWI
Fysicon BV
Cardiovascular · 433d
Cleared Aug 22, 2025
CARTO™ 3 EP Navigation System V8.1
K252302 · DQK
Biosense Webster, Inc.
Cardiovascular · 29d
Cleared Aug 22, 2025
CoraForce Microcatheter, CoraFlex Microcatheter
K251277 · DQY
Reflow Medical, Inc.
Cardiovascular · 120d
Cleared Aug 22, 2025
CPS Locator 3D Delivery Catheter
K250147 · DQY
Centerpoint Systems
Cardiovascular · 213d
Cleared Aug 18, 2025
PnueAira (PNCU-01)
K251086 · JOW
Biotab, LLC
Cardiovascular · 131d
Cleared Aug 15, 2025
Zio® monitor (DFG0001)
K243650 · DSH
iRhythm Technologies, Inc.
Cardiovascular · 262d
Cleared Aug 12, 2025
Eko Foundation Analysis Software with Transformers (EFAST)
K251494 · DQD
Eko Health, Inc.
Cardiovascular · 89d
Cleared Aug 08, 2025
Coretech Compression System (Coretech RHB3003)
K250817 · JOW
Vive Health, LLC
Cardiovascular · 143d
Cleared Aug 06, 2025
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP...
K251120 · DXN
Microlife Corporation
Cardiovascular · 117d
Cleared Aug 06, 2025
Cardiologs Holter Platform
K250569 · DPS
Philips France Commercial
Cardiovascular · 161d
Cleared Aug 04, 2025
Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors...
K251762 · KFM
Spectrum Medical S.R.L.
Cardiovascular · 56d
Cleared CT Aug 04, 2025
iHealth Compare Wireless Blood Pressure Monitor(BP-300C)
K251113 · DXN
Andon Health Co, Ltd.
Cardiovascular · 115d
Cleared Jul 31, 2025
BeneVision Central Monitoring System
K242728 · MSX
Shenzhen Mindray Bio-Medical...
Cardiovascular · 324d
Cleared Jul 30, 2025
EnSite™ X EP System
K251234 · DQK
Abbott Medical
Cardiovascular · 99d
Cleared Jul 30, 2025
ArteVu
K244007 · DXN
Cardio Ring Technologies, Inc. Taiwan...
Cardiovascular · 216d