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
15409–15432 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Jul 13, 1984
AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT
K842113 · DRE
Mallinckrodt Critical Care
Cardiovascular · 116d
Cleared Jul 13, 1984
RAAF DUAL LUMEN CATHETER
K842176 · DQY
Quinton, Inc.
Cardiovascular · 35d
Cleared Jul 13, 1984
ADVANCED CARDIOVASCULAR-CORONARY GUID
K842195 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 39d
Cleared Jul 11, 1984
COOK PACEMAKER 215 UNIPOLAR CARDIAC-
K841928 · DXY
Cook Pacemaker Corp.
Cardiovascular · 62d
Cleared Jul 11, 1984
COOK PACEMAKER 216 BIPOLAR CARDIAC -
K841983 · DXY
Cook Pacemaker Corp.
Cardiovascular · 57d
Cleared Jul 06, 1984
MULTIVARIATE DIGITAL CARDIOGRAPH
K840875 · DQK
Clinical Microsystems Intl.
Cardiovascular · 130d
Cleared Jul 06, 1984
PULSE GENERATOR 678L
K841233 · DXY
Siemens Elema AB
Cardiovascular · 106d
Cleared Jul 06, 1984
COOK PACEMAKER CORP. 115 UNIPOLAR CARDI
K842081 · DXY
Cook Pacemaker Corp.
Cardiovascular · 44d
Cleared Jul 06, 1984
JET VENTILATION ADAPTOR
K842456
Portex, Inc.
Cardiovascular · 14d
Cleared Jul 02, 1984
CARDIO EXPRESS 100 HOLTER SCANNER
K840622 · DSI
Del Mar Avionics
Cardiovascular · 139d
Cleared Jul 02, 1984
ACS SOF-T GUIDE WIREE
K840795 · DQT
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 130d
Cleared Jul 02, 1984
10.5 FRENCH DILATOR, 15CM, W/LUER LOCK
K841995 · DRE
Quinton, Inc.
Cardiovascular · 48d
Cleared Jun 26, 1984
PULSE GENERATOR 728, 728B & 728L
K841226 · DXY
Siemens Elema AB
Cardiovascular · 96d
Cleared Jun 26, 1984
PULSE GENERATOR 718B & 718L
K841228 · DXY
Siemens Elema AB
Cardiovascular · 96d
Cleared Jun 26, 1984
PULSE GENERATOR 688B & 688L
K841231 · DXY
Siemens Elema AB
Cardiovascular · 96d
Cleared Jun 25, 1984
PULSE GENERATOR 698, 698B & 698L
K841229 · DXY
Siemens Elema AB
Cardiovascular · 95d
Cleared Jun 25, 1984
NEOS M
K841636 · DXY
Biotronik Sales, Inc.
Cardiovascular · 67d
Cleared Jun 25, 1984
PULSE GENERATOR KALOS-04
K841950 · DXY
Biotronik Sales, Inc.
Cardiovascular · 52d
Cleared Jun 22, 1984
TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC
K840023 · DRS
American Bentley
Cardiovascular · 169d
Cleared Jun 22, 1984
HEART-CHECK ECG TRANSMITTER
K841875
Physio Ventures, Inc.
Cardiovascular · 46d
Cleared Jun 19, 1984
Q-MED ELECTRODE
K840465 · DRX
Qmed, Inc.
Cardiovascular · 137d
Cleared Jun 15, 1984
AUTOMATED NON-INVASIVE PRESSURE MODULE
K840909 · DXN
Gould, Inc.
Cardiovascular · 107d
Cleared Jun 14, 1984
DIGITAL SPHYGMOMANOMETER UA-254
K841380 · DXN
Promedical Industries, Inc.
Cardiovascular · 73d
Cleared Jun 14, 1984
DIGITAL SPHYGMOMANOMETER UA-273
K841381 · DXN
Promedical Industries, Inc.
Cardiovascular · 73d