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
9505–9528 of 18,110
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 13, 1999
ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX
K983575 · DXN
Datascope Corp.
Cardiovascular · 212d
Cleared May 11, 1999
TRACER O-T-W MAPPING DEVICE
K972803 · DRF
Cardima, Inc.
Cardiovascular · 652d
Cleared May 11, 1999
ZYMED TELEMETRY SYSTEM: MODEL EASIVIEW
K990093 · DSI
Agilent Technologies
Cardiovascular · 120d
Cleared May 07, 1999
EMCEE INFUSION INTRODUCER SHEATH, EMCEE INFUSION INTRODUCER SET DILATOR,...
K983039 · DYB
Schneider/Namic
Cardiovascular · 249d
Cleared May 05, 1999
LIFEPAK 500 BIPHASIC
K983393 · MKJ
Physio-Control Corp.
Cardiovascular · 222d
Cleared May 05, 1999
MODIFICATION TO ULTRA-SELECT GUIDEWIRE
K991194 · DQX
Microvena Corp.
Cardiovascular · 27d
Cleared May 04, 1999
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD, MODELS PT-45509...
K990829 · MCW
Arrow Intl., Inc.
Cardiovascular · 53d
Cleared Apr 29, 1999
HI-TORQUE BALANCE TREK GUIDE WIRE
K991152 · DQX
Guidant Corp.
Cardiovascular · 23d
Cleared Apr 28, 1999
TRINITY II SINGLE CHAMBER DVT PUMP
K983680 · JOW
Delphi Consulting Group
Cardiovascular · 190d
Cleared Apr 28, 1999
BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471
K984223 · DXN
Citizen Watch Co., Ltd.
Cardiovascular · 154d
Cleared Apr 23, 1999
COWBOY XV
K981311 · JOW
Kci New Technologies, Inc.
Cardiovascular · 378d
Cleared Apr 22, 1999
BI-DIRECTIONAL TUNNELER
K991027 · DSY
Impra, Inc.
Cardiovascular · 24d
Cleared Apr 21, 1999
ENSITE 3000 SYSTEM
K983456 · MTD
Endocardial Solutions, Inc.
Cardiovascular · 203d
Cleared Apr 20, 1999
QUICKDRAW VENOUS CANNULA
K981995 · DWF
Heartport, Inc.
Cardiovascular · 316d
Cleared Apr 19, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, HP VIRIDIA CMS 24/26, HP VIRIDIA...
K990972 · DSI
Hewlett-Packard GmbH
Cardiovascular · 27d
Cleared Apr 16, 1999
COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER
K983830 · LIT
Mallinckroot, Inc.
Cardiovascular · 168d
Cleared Apr 16, 1999
NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES
K990031 · LOS
Nihon Kohden America, Inc.
Cardiovascular · 101d
Cleared Apr 15, 1999
NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES
K984504 · LOS
Nihon Kohden America, Inc.
Cardiovascular · 118d
Cleared Apr 13, 1999
HOLTER 2000
K990170 · MLO
Zymed Medical Instrumentation
Cardiovascular · 84d
Cleared Apr 12, 1999
CARDIAC DIAGNOSTIC SYSTEM MODEL CH 2000
K983102 · DQK
Cambridge Heart, Inc.
Cardiovascular · 221d
Cleared Apr 12, 1999
PVR-100/VASOGRAM
K990123 · JOM
Vasocor, Inc.
Cardiovascular · 89d
Cleared Apr 09, 1999
TRACER
K982617 · MWJ
Heartland Medical Systems, Inc.
Cardiovascular · 256d
Cleared Apr 08, 1999
ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX...
K982365 · DXC
Geister Medizin Technik GmbH
Cardiovascular · 275d
Cleared Apr 08, 1999
ACUSEAL CARDIOVASCULAR PATCH
K984526 · DXZ
W.L. Gore & Associates, Inc.
Cardiovascular · 108d