FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cardiovascular ×
18,053 results
13849–13872 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 24, 1987
OXYGENATOR MODEL NO. BENTLEY 5 PLUS
K872133 · DTZ
American Bentley
Cardiovascular · 83d
Cleared Aug 21, 1987
ACS HI-TORQUE FLEX-T GUIDE WIRE (MODIFICATION)
K872220 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 73d
Cleared Aug 18, 1987
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438
K865098 · DTB
Telectronics, Inc.
Cardiovascular · 231d
Cleared Aug 14, 1987
ANDRIES PHYSICAL ASSESSMENT COMPUTER
K870545 · DQC
Andries Tek, Inc.
Cardiovascular · 185d
Cleared Aug 14, 1987
MASCOT CW DOPPLER SYSTEM
K871212 · JOP
Imex Medical Systems, Inc.
Cardiovascular · 141d
Cleared Aug 12, 1987
DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)
K870215 · LIT
Cook, Inc.
Cardiovascular · 204d
Cleared Aug 12, 1987
PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
K871080 · DQY
Catheter Technology Corp.
Cardiovascular · 147d
Cleared Aug 12, 1987
THE TELESCAN C.A.R.E. SYSTEM
K871587 · DSH
Telescan Medical Systems
Cardiovascular · 110d
Cleared Aug 12, 1987
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
K871992 · DXY
Telectronics, Inc.
Cardiovascular · 78d
Cleared Aug 12, 1987
DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES
K872159 · DWF
Shiley, Inc.
Cardiovascular · 69d
Cleared Aug 12, 1987
DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET
K872161 · DTL
Shiley, Inc.
Cardiovascular · 69d
Cleared Aug 12, 1987
DOUBLE LUMEN CATHETER
K872248 · DQO
Cordis Corp.
Cardiovascular · 61d
Cleared Aug 12, 1987
CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY)
K872485 · DXE
Ideas For Medicine, Inc.
Cardiovascular · 51d
Cleared Aug 11, 1987
QUANTASCOPE
K870442 · DXR
Vital Science Corp.
Cardiovascular · 189d
Cleared Aug 11, 1987
TRANSCOR RADIO-STETHOSCOPE MB
K872234 · DSH
Transcor, Inc.
Cardiovascular · 62d
Cleared Aug 10, 1987
SSD-725 ULTRASOUND SECTOR SCANNER
K870607 · JOP
Ge Medical Systems Information...
Cardiovascular · 180d
Cleared Aug 10, 1987
MEDTRONIC CLASSIX MODELS 8436/8437/8438
K871866 · DXY
Medtronic Vascular
Cardiovascular · 89d
Cleared Aug 07, 1987
CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEM
K870150 · JOP
Cardio Metrics, Inc.
Cardiovascular · 206d
Cleared Aug 03, 1987
ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODE
K871441 · DRX
Nitto Denko America, Inc.
Cardiovascular · 112d
Cleared Aug 03, 1987
CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS
K871774 · DTR
Gish Biomedical, Inc.
Cardiovascular · 89d
Cleared Aug 03, 1987
ARGYLE VASCULAR BYPASS SET
K871844 · DWF
Sherwood Medical Co.
Cardiovascular · 87d
Cleared Aug 03, 1987
MODIFIED INFO INSERTS FOR PRUITT IRRI.-OCCLU. CATH
K872154 · DQT
Ideas For Medicine, Inc.
Cardiovascular · 63d
Cleared Jul 31, 1987
SEAMED MODEL 3200
K872551 · DTE
Seamed Corp.
Cardiovascular · 32d
Cleared Jul 29, 1987
VITALNET(TM) SYSTEM (DINAMAP(TM), MODEL 2200)
K871418 · DXN
Critikon Company, LLC
Cardiovascular · 112d