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
7441–7464 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Dec 16, 2004
VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5,...
K033266 · DQK
Medical Imaging Applications, LLC
Cardiovascular · 434d
Cleared Dec 13, 2004
6F Z4 GUIDE CATHETER
K042489 · DQY
Medtronic Vascular
Cardiovascular · 90d
Cleared Dec 10, 2004
VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR
K032825 · DXN
Mars Medical Products Co., Ltd.
Cardiovascular · 457d
Cleared Dec 10, 2004
MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM
K042784 · DXT
Medrad, Inc.
Cardiovascular · 65d
Cleared Dec 09, 2004
ACS MODEL NCP-2
K042413 · DRN
Applied Cardiac Systems
Cardiovascular · 93d
Cleared Dec 09, 2004
VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2
K043103 · DXG
Edwards Lifesciences, LLC
Cardiovascular · 30d
Cleared Dec 08, 2004
BIOZDX HEMODYNAMIC MONITOR
K041294 · DSB
Cardiodynamics International Corp.
Cardiovascular · 208d
Cleared Dec 06, 2004
H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM
K043186 · DXN
Health & Life Co., Ltd.
Cardiovascular · 19d
Cleared Dec 03, 2004
HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES
K042148 · DQK
Ge Medical Syst. Information...
Cardiovascular · 116d
Cleared Dec 03, 2004
A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512
K042967 · DXN
A&D Engineering, Inc.
Cardiovascular · 36d
Cleared Dec 03, 2004
PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49,...
K043023 · MJN
LeMaitre Vascular, Inc.
Cardiovascular · 30d
Cleared Dec 02, 2004
WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES
K041693 · DXN
Hangzhou Hua'An Medical & Health...
Cardiovascular · 163d
Cleared Nov 30, 2004
ENPATH SAFETY INTRODUCER
K041708 · DYB
Enpath Medical Incorporated
Cardiovascular · 160d
Cleared Nov 30, 2004
OPTIV ANTAGE DH POWER INJECTION SYSTEM
K042744 · DXT
Mallinckrodt Inc., Liebel-Flarsheim...
Cardiovascular · 57d
Cleared Nov 24, 2004
GUIDEWIRES
K042264 · DQX
Rocket Medical Plc
Cardiovascular · 93d
Cleared Nov 24, 2004
COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE
K042996 · DQX
Volcano Therapeutics, Inc.
Cardiovascular · 23d
Cleared Nov 24, 2004
COMMANDER II
K043096 · DXN
Cardiocom
Cardiovascular · 15d
Cleared Nov 22, 2004
VENTURE WIRE CONTROL CATHETER, MODEL WCC
K042910 · DQY
Velocimed, Inc.
Cardiovascular · 32d
Cleared Nov 18, 2004
METRICATH SYSTEM
K042685 · DQO
Angiometrx, Inc.
Cardiovascular · 50d
Cleared Nov 12, 2004
NICOM
K042144 · DXG
Cheetah Medical, Inc.
Cardiovascular · 95d
Cleared Nov 12, 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
K042611 · DQX
Cook, Inc.
Cardiovascular · 49d
Cleared Nov 12, 2004
THE PHILIPS MP20, MP30, MP40, MP50, MP60, MP70, AND MP90 INTELLIVUE PATIENT...
K042845 · MSX
Philips Medizin Systeme Boblingen GmbH
Cardiovascular · 28d
Cleared Nov 12, 2004
RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM
K042908 · NTE
Guidant Corp.
Cardiovascular · 22d
Cleared Nov 10, 2004
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF,...
K042853 · DXN
Health & Life Co., Ltd.
Cardiovascular · 26d