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
5233–5256 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Feb 15, 2011
PHILIPS ECG LEADWIRE SET
K110287 · DSA
Philips Medical Systems
Cardiovascular · 15d
Cleared Feb 15, 2011
VANTAGE ABI
K103693 · DXN
Summit Doppler Systems, Inc.
Cardiovascular · 60d
Cleared Feb 15, 2011
ADVANCED MEMBRANE GAS EXCHANGE (AMG), AMG OXYGENALING MODULE, AMG VENOUS...
K102109 · DTZ
Eurosets S.R.L
Cardiovascular · 202d
Cleared Feb 14, 2011
FUSTAR STEERABLE INTRODUCERS
K100184 · DQY
Lifetech Scientific (Shenzhen) Co., Ltd.
Cardiovascular · 389d
Cleared Feb 11, 2011
NC TREK RX CORONARY DILATATION CATHETER
K110134 · LOX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 24d
Cleared Feb 11, 2011
EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER
K110103 · DQO
Edwards Lifesciences, LLC
Cardiovascular · 29d
Cleared Feb 11, 2011
MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R)...
K103386 · DQY
Medtronic, Inc.
Cardiovascular · 85d
Cleared Feb 11, 2011
COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM...
K102714 · KRD
Boston Scientific Corp
Cardiovascular · 144d
Cleared Feb 10, 2011
HI-TORQUE BALANCE MIDDLEWEIGHT ELITE
K103101 · DQX
Abbott Vascular-Cardiac Therapies
Cardiovascular · 113d
Cleared Feb 08, 2011
DEFIBRILLATOR ANALYZER - DA-2006P
K110192 · DRL
Bc Group International, Inc.
Cardiovascular · 15d
Cleared Feb 08, 2011
INTEL HEALTH GUIDE
K103276 · DRG
Intel Corporation Digital Health Group
Cardiovascular · 95d
Cleared Feb 08, 2011
SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODES
K103186 · MKJ
Leonhard Lang GmbH
Cardiovascular · 102d
Cleared Feb 04, 2011
BLANKETROL II HYPER-HYPOTHERMIA TEMPERATURE MANAGMENT SYSTEM
K110104 · DWJ
Cincinnati Sub-Zero Products, Inc.
Cardiovascular · 22d
Cleared Feb 04, 2011
SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
K103732 · DXN
Spacelabs Healthcare, Ltd.
Cardiovascular · 44d
Cleared Feb 04, 2011
AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0
K103516 · DQD
Inovise Medical, Inc.
Cardiovascular · 66d
Cleared Feb 04, 2011
MH1 MICROHOLTER RECORDER
K101969 · MWJ
Exelys, LLC
Cardiovascular · 206d
Cleared Feb 02, 2011
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
K110009 · DQX
Cook, Inc.
Cardiovascular · 30d
Cleared Feb 02, 2011
CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K103347 · DSY
Intervascular Sas
Cardiovascular · 79d
Cleared Feb 02, 2011
ARSTASIS ONE LATCHWIRE ACCESS SYSTEM
K103143 · DYB
Arstasis, Inc.
Cardiovascular · 100d
Cleared Feb 02, 2011
VASCULAIRE COMPRESSION SYSTEM
K103113 · JOW
Venous Health Systems, Inc.
Cardiovascular · 104d
Cleared Jan 28, 2011
ANS SYSTEM
K101016 · DPS
Caird Technology
Cardiovascular · 291d
Cleared Jan 27, 2011
4D MV-ASSESSMENT 2.0
K103782 · DQK
Tomtec Imaging Systems GmbH
Cardiovascular · 31d
Cleared Jan 26, 2011
VANTAGE VIEW SYSTEM
K110085 · DXJ
St Jude Medical
Cardiovascular · 15d
Cleared Jan 26, 2011
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM
K103780 · MJN
Micrus Endovascular Corporation
Cardiovascular · 30d