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
865–888 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Nov 21, 2023
CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H
K230834 · DPS
Trismed Co., Ltd.
Cardiovascular · 239d
Cleared Nov 17, 2023
EKGenius Smart System
K232974 · DPS
Ekgenius, LLC
Cardiovascular · 57d
Cleared Nov 17, 2023
Masimo W1
K232512 · DPS
Masimo Corporation
Cardiovascular · 91d
Cleared Nov 17, 2023
SENDERO Microcatheter
K231600 · DQY
Okami Medical, Inc.
Cardiovascular · 169d
Cleared Nov 17, 2023
Edwards Algorithm for Measurement of Blood Hemoglobin
K230612 · MUD
Edwards Lifesciences, LLC
Cardiovascular · 256d
Cleared Nov 16, 2023
D100 KIDS
K231652 · DTZ
Sorin Group Italia S.R.L.
Cardiovascular · 163d
Cleared Nov 09, 2023
Cardio P1
K231150 · DPS
Bionet Co., Ltd.
Cardiovascular · 202d
Cleared Nov 08, 2023
Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U,...
K231773 · DTZ
Qura S.R.L
Cardiovascular · 145d
Not Cleared Nov 08, 2023
Dream Sock
DEN220091 · QYU
Owlet Babycare, Inc.
Cardiovascular · 329d
Cleared Nov 03, 2023
Endophys Blood Pressure Monitor model BPM-30
K231586 · DSK
Endophys Technologies, LLC
Cardiovascular · 156d
Cleared Nov 03, 2023
Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature...
K231182 · NZE
Zoll Circulation, Inc.
Cardiovascular · 191d
Cleared Nov 02, 2023
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0)
K233407 · PZX
AtriCure, Inc.
Cardiovascular · 28d
Cleared Nov 01, 2023
Aventus Thrombectomy System
K232730 · QEW
Inquis Medical
Cardiovascular · 55d
Cleared Nov 01, 2023
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
K231414 · DTZ
Chalice Medical , Ltd.
Cardiovascular · 169d
Cleared Oct 31, 2023
LINQ II™ Insertable Cardiac Monitor (LNQ22)
K233320 · MXD
Medtronic, Inc.
Cardiovascular · 32d
Cleared Oct 31, 2023
FlexCath Contour™ Steerable Sheath
K232321 · DRA
Medtronic, Inc.
Cardiovascular · 89d
Cleared Oct 31, 2023
HemoSphere Alta Advanced Monitoring Platform
K232294 · DQK
Edwards Lifesciences, LLC
Cardiovascular · 91d
Cleared Oct 31, 2023
OCS Heart Leukocyte Depleting Filter
K231362 · DTM
TransMedics, Inc.
Cardiovascular · 173d
Cleared Oct 30, 2023
Empatica Health Monitoring Platform
K230457 · MWI
Empatica S.R.L.
Cardiovascular · 251d
Cleared Oct 28, 2023
AcuNav Crystal Ultrasound Catheter
K233270 · OBJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 29d
Cleared Oct 28, 2023
Mighty Wire Guide Wire
K230418 · DQX
Merit Medical Systems, Inc.
Cardiovascular · 254d
Cleared Oct 27, 2023
Polaris X™ Unidirectional Steerable Diagnostic Catheter
K233207 · DRF
Boston Scientific Corporation
Cardiovascular · 29d
Cleared Oct 27, 2023
Electronic Blood Pressure Monitor
K231310 · DXN
Shenzhen Jumper Medical Equipment...
Cardiovascular · 175d
Cleared Oct 26, 2023
Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT)
K233091 · KFM
Qura S.R.L
Cardiovascular · 30d