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
8521–8544 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 05, 2002
CENTRIFUGAL PUMP
K011838 · DWA
Stockert Instrumente GmbH
Cardiovascular · 238d
Cleared Feb 05, 2002
MEDTRONIC PHYSIO-CONTROL LIFEPAK 20 DEFIBRILLATOR/MONITOR/PACEMAKER
K012274 · LDD
Medtronic Physio-Control Corp.
Cardiovascular · 201d
Cleared Feb 05, 2002
VASCUPUNCTURE ACCESS WIRE
K012861 · DQX
Neometrics, Inc.
Cardiovascular · 165d
Cleared Feb 01, 2002
FIRSTSAVE STAR BIPHASIC, MODEL 9210/9200
K011901 · MKJ
Survivalink Corp.
Cardiovascular · 228d
Cleared Feb 01, 2002
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001
K012241 · DSI
Cardionet, Inc.
Cardiovascular · 199d
Cleared Feb 01, 2002
TM2000, MODEL 1
K013879 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 70d
Cleared Feb 01, 2002
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
K014016 · DWC
Minntech Corp.
Cardiovascular · 58d
Cleared Feb 01, 2002
DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410
K020022 · MWI
Ge Medical Systems Information...
Cardiovascular · 29d
Cleared Jan 31, 2002
GLOBALCARDIO
K013354 · DSH
Cardiocomm Solutions, Inc.
Cardiovascular · 114d
Cleared Jan 30, 2002
MEDITRON II THESTERTHOSCOPE SYSTEM
K013725 · DQD
Meditron AS
Cardiovascular · 82d
Cleared Jan 30, 2002
SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH
K014299 · DSB
Sorba Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jan 29, 2002
METAVISION CLINICAL INFORMATION SYSTEM
K012349 · MWI
Imdsoft, Ltd.
Cardiovascular · 189d
Cleared Jan 29, 2002
MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER
K020012 · DQO
Boston Scientific/Medi-Tech
Cardiovascular · 26d
Cleared Jan 28, 2002
CATHEFFECTS' DESAI VECTORCATH MAPPING SYSTEM
K012089 · DQK
Catheffects, LLC
Cardiovascular · 207d
Cleared Jan 25, 2002
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C
K013392 · OCL
Medtronic Vascular
Cardiovascular · 102d
Cleared Jan 25, 2002
ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
K013577 · DSY
Atrium Medical Corp.
Cardiovascular · 88d
Cleared Jan 25, 2002
MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM
K014223 · NFA
Medtronic Percusurge, Inc.
Cardiovascular · 30d
Cleared Jan 24, 2002
ANCURE SHEATH MODEL # 40315, 40320, 40325
K003889 · DYB
Guidant Cardiac and Vascular Surgery
Cardiovascular · 402d
Cleared Jan 24, 2002
MULTI-SNARE SET
K011783 · DXE
Pfm Produkte Fur Die Medizin AG
Cardiovascular · 231d
Cleared Jan 24, 2002
EPS320 CARDIAC STIMULATOR
K011826 · JOQ
Micropace Pty, Ltd.
Cardiovascular · 227d
Cleared Jan 24, 2002
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K012534 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 171d
Cleared Jan 24, 2002
BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664
K012749 · DQO
Biocardia, Inc.
Cardiovascular · 161d
Cleared Jan 23, 2002
KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
K010923 · MHX
Siemens Elema AB
Cardiovascular · 302d
Cleared Jan 23, 2002
VASOCOR VASCULAR DIAGNOSTIC CENTER (MODEL 300)
K011625 · DXN
Vasocor, Inc.
Cardiovascular · 243d