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
14809–14832 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 22, 1985
DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO
K850482 · DSP
Datascope Corp.
Cardiovascular · 196d
Cleared Aug 22, 1985
MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT
K852388 · DQY
Quinton, Inc.
Cardiovascular · 73d
Cleared Aug 20, 1985
CORDIS PTA CATHETER-PERCUTANEOUS CATHETER
K844913 · LIT
Cordis Corp.
Cardiovascular · 245d
Cleared Aug 19, 1985
ECS 502
K840717 · DRT
Robert Bosch Corp.
Cardiovascular · 549d
Cleared Aug 19, 1985
DESERET THERMODILUTION CARDIAC OUTPUT
K841967 · DXG
Parke-Davis Co.
Cardiovascular · 461d
Cleared Aug 19, 1985
VSM MODELS A & B
K851916 · DRT
Physio-Control Corp.
Cardiovascular · 109d
Cleared Aug 19, 1985
DOME, DISPOSABLE, STERILE
K851989 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 104d
Cleared Aug 19, 1985
COPAL UA-512 DIGITAL BLOOD PRESSURE MONITOR
K852564 · DXN
Takeda Medical, Inc.
Cardiovascular · 91d
Cleared Aug 19, 1985
CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR
K853425 · DXY
Cardio-Pace Medical, Inc.
Cardiovascular · 5d
Cleared Aug 16, 1985
PTCA GUIDING CATHETER
K851947 · DYB
Cordis Corp.
Cardiovascular · 105d
Cleared Aug 16, 1985
FLUSH DEVICE, AUTOMATIC
K851987 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 101d
Cleared Aug 16, 1985
ADMINISTRATION SET
K851988 · DRS
Transamerica Delaval, Inc.
Cardiovascular · 101d
Cleared Aug 14, 1985
TECA TC2-64 TRANSCRANIAL DOPPLER
K850137 · DPW
Teca, Inc.
Cardiovascular · 212d
Cleared Aug 12, 1985
AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU
K851323 · DWF
C.R. Bard, Inc.
Cardiovascular · 130d
Cleared Aug 09, 1985
CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD
K851897 · DTD
Cardiac Control Systems, Inc.
Cardiovascular · 101d
Cleared Aug 09, 1985
CAPIOX BLOOD SAMPLING MANIFOLD
K852086 · DTL
Terumo Medical Corp.
Cardiovascular · 88d
Cleared Aug 09, 1985
BARD-PARKER IRRIGATION CATHETER
K852099 · DQY
Bd Becton Dickinson Vacutainer...
Cardiovascular · 86d
Cleared Aug 09, 1985
FOAM ECG ELECTRODES
K852177 · DRX
Clinical Data, Inc.
Cardiovascular · 81d
Cleared Aug 09, 1985
PRESSURE DISPLAY BOX #60000/TUBING SET #61000
K852232 · DXS
Dlp, Inc.
Cardiovascular · 79d
Cleared Aug 09, 1985
PULMONARY VEIN CLAMP
K852479 · DXC
None
Cardiovascular · 59d
Cleared Aug 06, 1985
APM DISPOS. BLOOD PRESSURE TRANSDUCER
K851888 · DRS
Honeywell, Inc.
Cardiovascular · 97d
Cleared Aug 06, 1985
LITEGUARD 9
K851924 · LDD
Temtech , Ltd.
Cardiovascular · 96d
Cleared Aug 06, 1985
MEDTRONIC MODEL 5561
K852356 · DTD
Medtronic Vascular
Cardiovascular · 64d
Cleared Aug 06, 1985
CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA
K852435 · DXY
Cardiac Control Systems, Inc.
Cardiovascular · 57d