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
577–600 of 18,182
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