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
8665–8688 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Oct 02, 2001
SMARTFLOW
K012947 · DQK
Florence Medical , Ltd.
Cardiovascular · 28d
Cleared Oct 02, 2001
HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT
K012952 · DSY
Boston Scientific/Medi-Tech
Cardiovascular · 28d
Cleared Sep 28, 2001
VYGON SPLIT CANNULA INTRODUCER
K010913 · DYB
Vygon Corp.
Cardiovascular · 185d
Cleared Sep 28, 2001
2010 PLUS HOLTER FOR WINDOWS
K010949 · MLO
Agilent Technologies
Cardiovascular · 183d
Cleared Sep 28, 2001
MODIFICATION TO: LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
K012428 · MKJ
Medtronic Physio-Control Corp.
Cardiovascular · 59d
Cleared Sep 28, 2001
BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K012913 · DQY
C.R. Bard, Inc.
Cardiovascular · 29d
Cleared Sep 28, 2001
MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000
K012926 · MTD
Endocardial Solutions, Inc.
Cardiovascular · 28d
Cleared Sep 27, 2001
DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS...
K010478 · DTZ
Dideco
Cardiovascular · 219d
Cleared Sep 27, 2001
VITALLINK 1200 MOBILE VITAL SIGNS SYSTEMS (VL 1200 SYSTEM)
K010732 · MWI
Telemedic Systems, Inc.
Cardiovascular · 199d
Cleared Sep 27, 2001
AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
K013084 · DTM
Medtronic Perfusion Systems
Cardiovascular · 13d
Cleared Sep 26, 2001
BLY-501 ADAPTOR
K012540 · DPS
Micromedical Industries, Ltd.
Cardiovascular · 50d
Cleared Sep 25, 2001
ULTRAFLEX EV HEMOSTASIS INTRODUCER
K012922 · DYB
St Jude Medical
Cardiovascular · 25d
Cleared Sep 24, 2001
PORTABLE INTENSIVE CARE UNIT
K012030 · MKJ
Medical Research Laboratories, Inc.
Cardiovascular · 88d
Cleared Sep 21, 2001
STS RANGE , MODELS STS20,STS30,STS40
K012008 · JOW
Huntleigh Healthcare, Inc.
Cardiovascular · 86d
Cleared Sep 20, 2001
SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
K011988 · OCL
Cardiofocus, Inc.
Cardiovascular · 86d
Cleared Sep 20, 2001
PRECLUDE PERICARDIAL MEMBRANE
K012098 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 77d
Cleared Sep 17, 2001
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
K012898 · DTR
Cobe Cardiovascular, Inc.
Cardiovascular · 19d
Cleared Sep 14, 2001
E-STETH ELECTRONIC STETHOSCOPE
K011898 · DQD
E-Med Innovations, Inc.
Cardiovascular · 88d
Cleared Sep 14, 2001
TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T
K012743 · DRY
Medtronic Perfusion Systems
Cardiovascular · 29d
Cleared Sep 14, 2001
TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
K012747 · DPT
Medtronic Perfusion Systems
Cardiovascular · 29d
Cleared Sep 14, 2001
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
K012837 · MLD
Datex-Ohmeda
Cardiovascular · 22d
Cleared Sep 12, 2001
NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL...
K011918 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 84d
Cleared Sep 12, 2001
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
K011980 · DTE
Pace Medical
Cardiovascular · 79d
Cleared Sep 10, 2001
CG-2211 SELFCHECK ECG TRANSMITTER
K012223 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 56d