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
15793–15816 of 18,053
Search insights Median review: 90d Cleared: 100% Top manufacturer: Medtronic Vascular Lead specialty: Cardiovascular
Cleared Aug 12, 1983
DISP. TRANSDUCER W/MONITORING KIT TRANS
K831506 · DRS
Sorensen Research
Cardiovascular · 93d
Cleared Aug 12, 1983
PHYSIOLOGICAL MONITOR #902
K831578 · DRT
Novametrix Medical Systems, Inc.
Cardiovascular · 87d
Cleared Aug 12, 1983
FOGARTY-CHIN PERIPHERAL INTRAOPERATIVE
K831659 · LIT
American Edwards Laboratories
Cardiovascular · 81d
Cleared Aug 12, 1983
INTRACARDIA SUCKERS
K831759 · DWF
Research Industries Corp.
Cardiovascular · 72d
Cleared Aug 12, 1983
VARIOUS CARDIOVASCULAR SURGICAL DEVICE
K831769 · DWF
Research Industries Corp.
Cardiovascular · 72d
Cleared Aug 12, 1983
PRESSURE MONITORING IV BOTTLE CAP
K831867 · DRS
Alto Development Corp.
Cardiovascular · 63d
Cleared Aug 12, 1983
ELECATH BALTHERM TLC THERMAL DILUTION
K831945 · DYG
Electro-Catheter Corp.
Cardiovascular · 57d
Cleared Aug 12, 1983
ELECTRONIC BLOOD PRESS. METER-ZH-820P
K832075 · DXN
Panasonic Co. Div. Matsu Elec. Corp....
Cardiovascular · 45d
Cleared Aug 12, 1983
ELECTRODE LEADS 030-267 & 030-268
K832110 · DTB
Telectronics, Inc.
Cardiovascular · 43d
Cleared Aug 12, 1983
CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI
K832124 · DWF
Med-West, Inc.
Cardiovascular · 43d
Cleared Aug 12, 1983
AMPLATZ HEPARIN COATED CATHETER
K832178 · DQY
Cook, Inc.
Cardiovascular · 37d
Cleared Aug 12, 1983
UNIPOLAR-E ENDOCARDIAL TINED LEAD
K832245 · DTB
Cook Pacemaker Corp.
Cardiovascular · 32d
Cleared Aug 12, 1983
MODEL F UNIPOLAR ENDOCARDIAL LEAD-
K832255 · DTB
Cook Pacemaker Corp.
Cardiovascular · 32d
Cleared Aug 12, 1983
LIFELINE PACING LEADS #471-07 &09
K832409 · DTB
Intermedics, Inc.
Cardiovascular · 22d
Cleared Aug 11, 1983
CARDIVAN BLOOD PRESSURE MONITOR
K830682 · DXN
Paramed Technology, Inc.
Cardiovascular · 174d
Cleared Aug 11, 1983
PANASONIC MODEL EW-213
K831151 · DXN
Panasonic Co. Div. Matsu Elec. Corp....
Cardiovascular · 125d
Cleared Aug 11, 1983
DISPOSABLE PRESSURE TRANSDUCER#14004195
K831698 · DRS
Norton Performance Plastics Corp.
Cardiovascular · 78d
Cleared Aug 11, 1983
HR 100T
K831955 · JOM
Thought Technology , Ltd.
Cardiovascular · 55d
Cleared Aug 11, 1983
CARDIOPLEGIA RESERVOIR-#500926
K831966 · DTN
American Bentley
Cardiovascular · 52d
Cleared Aug 11, 1983
EDSLAB PRESSURE GAUGE
K832323 · MAV
American Edwards Laboratories
Cardiovascular · 27d
Cleared Aug 10, 1983
UNIVERSAL CORONARY CANNULA
K831330 · DWF
Possis Medical, Inc.
Cardiovascular · 107d
Cleared Aug 08, 1983
MODEL 327T UNIPOLAR CARDIAC PULSE GEN
K832052 · DXY
Cook Pacemaker Corp.
Cardiovascular · 42d
Cleared Aug 08, 1983
VENOUS CATHETER
K832064 · DQY
Cardio Search, Inc.
Cardiovascular · 42d
Cleared Jul 29, 1983
VITALINE 2
K822856
American Heartline, Inc.
Cardiovascular · 305d