FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cardiovascular ×
18,151 results
16345–16368 of 18,151
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared May 25, 1982
CARDIAC CATHERIZATION LAB MICROPROCESS
K820194 · DXG
Compu-Cath Corp.
Cardiovascular · 120d
Cleared May 25, 1982
BLOOD FLOW ANALYZER
K820959 · DSB
Biofax Medical Instrumentation Co.
Cardiovascular · 49d
Cleared May 25, 1982
MEDTRONIC S3 TM SYSTEM
K821004 · DYG
Medtronic Vascular
Cardiovascular · 46d
Cleared May 25, 1982
IN-LINE OXYGEN MONITORING SYSTEM
K821159 · DRY
G.D. Searle and Co.
Cardiovascular · 33d
Cleared May 25, 1982
ONE HAND ANEROID SPHYGMOMANOMETER
K821232 · DXQ
Abco Dealers, Inc.
Cardiovascular · 27d
Cleared May 25, 1982
MODELS 78504A & 78508A PATIENT MON. SYS
K821368 · DRT
Hewlett-Packard Co.
Cardiovascular · 15d
Cleared May 25, 1982
RED DOT MONITORING ELECTRODES #2260/65
K821438 · DRX
3M Company
Cardiovascular · 12d
Cleared May 25, 1982
PRESSURE TUBING-ADULT & PEDIATRIC
K821450 · DRS
Gould, Inc.
Cardiovascular · 11d
Cleared May 25, 1982
CARDIOCASSETTE II #363
K821453 · DSH
Birtcher Corp.
Cardiovascular · 11d
Cleared May 24, 1982
SCIMED MODEL SC 3000
K820954 · DTP
Scimed Life Systems, Inc.
Cardiovascular · 48d
Cleared May 24, 1982
CARE MODEL IP 4500 AUTO SCANNERR
K821015 · DRT
Care Monitoring Systems
Cardiovascular · 42d
Cleared May 18, 1982
SC-2500F CARDIOTOMY RESERVIOR
K813268 · DTN
Scimed Life Systems, Inc.
Cardiovascular · 179d
Cleared May 18, 1982
PRESSURE-STAT
K820667 · DXN
Alvin H. Sacks, Ph.D.
Cardiovascular · 68d
Cleared May 18, 1982
MEMOPORT C
K820881 · DSI
Litton Medical Electronics
Cardiovascular · 49d
Cleared May 18, 1982
PMS-2 PRESSURE MONITOR SEPARATOR
K820912 · DXS
Delta Medical Industries
Cardiovascular · 47d
Cleared May 18, 1982
FLOW DIRECTED THERMAL-DILUTION CATHETER
K821056
Oximetrix, Inc.
Cardiovascular · 33d
Cleared May 18, 1982
FLOW DIRECTED THERMAL-DILUTION INFUSION
K821057 · DYG
Oximetrix, Inc.
Cardiovascular · 32d
Cleared May 18, 1982
HEPARIN COATED THERMODILUTION CATHETER
K821099 · DYG
Kma, Inc.
Cardiovascular · 28d
Cleared May 18, 1982
MEDITRACE PELLET ELECTRODE
K821137 · DRX
Graphic Controls Corp.
Cardiovascular · 28d
Cleared May 18, 1982
SUBMISSION CORONARY CANNULA
K821149 · DWF
Dlp, Inc.
Cardiovascular · 25d
Cleared May 18, 1982
FED RINGED-TEX VASCULAR GRAFT
K821158 · DSY
W.L. Gore & Associates, Inc.
Cardiovascular · 21d
Cleared May 18, 1982
EVENTMASTER 3 HOLTER EVENT SCANNER
K821173 · DSF
Instruments For Cardiac Research
Cardiovascular · 22d
Cleared May 18, 1982
HEPARIN COATED THERMODILUTION CATHETER
K821235 · DYG
Gould, Inc.
Cardiovascular · 20d
Cleared May 07, 1982
PROGRAMMALITH II, #225 & 226
K821003 · DXY
Pacesetter Systems
Cardiovascular · 28d