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
505–528 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 14, 2025
WARD-CSS (v1.2.x)
K241958 · MWI
Ward 24/7 Aps
Cardiovascular · 226d
Cleared Feb 12, 2025
Etiometry Platform (DAV 5.4 RAE 9.2)
K241479 · PPW
Etiometry, Inc.
Cardiovascular · 264d
Cleared Feb 12, 2025
OptoMonitor 3
K241418 · DXO
Opsens, Inc.
Cardiovascular · 268d
Cleared Feb 11, 2025
Wrist Blood Pressure Monitor (XY-W01A, XY-W01B)
K241634 · DXN
Guangdong Xinyu Electronic and...
Cardiovascular · 250d
Cleared Feb 07, 2025
Electronic Blood Pressure Monitor
K243661 · DXN
Hetaida Technology Co., Ltd.
Cardiovascular · 72d
Cleared Feb 06, 2025
CROSSLEAD 0.014inch
K241702 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 238d
Cleared Feb 05, 2025
Accurate Mini Non-invasive blood pressure monitor (AMB-001)
K242352 · DXN
Accurate Meditech, Inc.
Cardiovascular · 181d
Cleared Feb 03, 2025
iCare APP
K243146 · MWI
Ihealth Labs, Inc.
Cardiovascular · 126d
Cleared Feb 03, 2025
Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08,...
K241590 · DXN
Guangdong Xinyu Electronic and...
Cardiovascular · 245d
Cleared Jan 31, 2025
Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
K242966 · DQO
Gentuity, LLC
Cardiovascular · 127d
Cleared Jan 31, 2025
Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel...
K241334 · LDF
C.R. Bard, Inc.
Cardiovascular · 266d
Cleared Jan 30, 2025
Rotarex Atherectomy System
K242757 · MCW
Bard Peripheral Vascular, Inc.
Cardiovascular · 140d
Cleared Jan 30, 2025
Wrist Blood Pressure Monitor (OHMS11, OHMS12)
K242568 · DXN
Shenzhen Zhongkemingwang...
Cardiovascular · 154d
Cleared Jan 23, 2025
Vios Monitoring System(TM) Model 2050
K241728 · DXN
Murata Vios, Inc.
Cardiovascular · 223d
Cleared Jan 23, 2025
Rotatable Connector (5944RL)
K241199 · LDF
Shenzhen Launch Electrical Co., Ltd.
Cardiovascular · 268d
Cleared Jan 19, 2025
Neonav ECG Tip Location System
K241910 · LJS
Navi Medical Technologies
Cardiovascular · 202d
Cleared Jan 17, 2025
Affera Integrated Mapping System
K243892 · DQK
Medtronic, Inc.
Cardiovascular · 30d
Cleared Jan 17, 2025
Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name:...
K243545 · DSA
Philips Medizin Systeme B?blingen GmbH
Cardiovascular · 63d
Cleared Jan 17, 2025
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline...
K242705 · LDF
Medtronic, Inc.
Cardiovascular · 130d
Cleared Jan 16, 2025
CloudHRV™ System (100-01-001)
K241217 · DPS
Inmedix, Inc.
Cardiovascular · 260d
Cleared Jan 15, 2025
AtriClip PRO-Mini LAA Exclusion System (PROM)
K243860 · PZX
AtriCure, Inc.
Cardiovascular · 30d
Cleared Jan 15, 2025
Ventrax™ Delivery System
K242873 · DQY
Merit Medical Systems, Inc.
Cardiovascular · 114d
Cleared Jan 15, 2025
Micro Ace Gold Advanced Micro Access System
K242229 · DRE
Merit Medical Systems, Inc.
Cardiovascular · 169d
Cleared Jan 15, 2025
Venera 608 Deep Vein Thrombosis (DVT) Prevention System
K241096 · JOW
Suzhou Minhua Medical Apparatus...
Cardiovascular · 268d