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
937–960 of 18,182
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 CT 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