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
337–360 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared 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 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 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